Eine Studie zu Amivantamab und mFOLFOX6 oder FOLFIRI im Vergleich zu Cetuximab und mFOLFOX6 oder FOLFIRI als Erstlinienbehandlung bei Teilnehmern mit KRAS/NRAS und BRAF-Wildtyp-inoperablem oder metastasiertem linksseitigem Darmkrebs (OrigAMI-2)
Eine randomisierte, offene Phase-3-Studie zu Amivantamab und mFOLFOX6 oder FOLFIRI im Vergleich zu Cetuximab und mFOLFOX6 oder FOLFIRI als Erstlinienbehandlung bei Teilnehmern mit KRAS/NRAS und BRAF-Wildtyp-inoperablem oder metastasiertem linksseitigem Darmkrebs
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Erweiterter Zugriff
Kontakte und Standorte
Studienkontakt
- Name: Study Contact
- Telefonnummer: 844-434-4210
- E-Mail: Participate-In-This-Study1@its.jnj.com
Studienorte
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Anderlecht, Belgien, 1070
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- Institut Jules Bordet
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Edegem, Belgien, 2650
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- Universitair Ziekenhuis Antwerpen
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Ghent, Belgien, 9000
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- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgien, 7100
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- Hopital de Jolimont
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Kortrijk, Belgien, 8500
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- Az Groeninge
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Leuven, Belgien, 3000
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- Universitair Ziekenhuis Leuven
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Liège, Belgien, 4000
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- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brasilien, 14780 070
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- Fundacao Pio XII
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Caxias do Sul, Brasilien, 95070 560
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- Fundacao Universidade de Caxias do Sul
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Jaú, Brasilien, 17210 080
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- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brasilien, 91350 200
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- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brasilien, 40050 410
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- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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Santa Maria, Brasilien, 97015 450
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- Clinica de Hematologia e Oncologia Viver Ltda
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São José do Rio Preto, Brasilien, 15090-000
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São Paulo, Brasilien, 01246 000
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São Paulo, Brasilien, 01509 900
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São Paulo, Brasilien, 05651 900
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Vitória, Brasilien, 29043 260
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Beijing, China, 100191
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- Peking University Third Hospital
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Beijing, China, 100142
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- Beijing Cancer Hospital
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Beijing, China, 100034
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- Peking University First Hospital
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Beijing, China, 100050
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- Beijing Friendship Hospital Capital Medical University
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Changchun, China, 130021
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Changsha, China, 410013
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- Hunan Cancer hospital
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Guangzhou, China, 510655
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- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, China, 519041
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- Guangdong Provincial People's Hospital
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Guangzhou, China, 510062
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- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310009
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- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, China, 310022
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- Zhejiang Cancer Hospital
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Hangzhou, China, 310003
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- The First Affiliated Hospital Zhejiang University College of Medicine
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Harbin, China, 150081
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- Harbin medical university cancer hospital
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Huizhou, China, 516001
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- Huizhou Central People's Hospital
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Nanchang, China, 330006
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Shanghai, China, 200032
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Shenyang, China, 110042
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- Liaoning Cancer Hospital and Institute
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Shenzhen, China, 518036
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Sichuan, China, 610044
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Taiyuan, China, 030001
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Tianjin, China, 300060
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Wuhan, China, 430079
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Essen, Deutschland, 45147
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Freiburg im Breisgau, Deutschland, 79110
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Petah Tikva, Israel, 4941492
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Ramat Gan, Israel, 52621
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Tel Aviv, Israel, 69710
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Meldola, Italien, 47014
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Milan, Italien, 20133
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Rozzano, Italien, 20089
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Chiba, Japan, 260 0801
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Chūōku, Japan, 104 0045
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Kashiwa, Japan, 277 8577
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Nagoya, Japan, 464-8681
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Osaka, Japan, 541 8567
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Osaka, Japan, 540 0006
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Shizuoka, Japan, 411 8777
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Suita, Japan, 565 0871
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Tokyo, Japan, 135 8550
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L6
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Toronto, Ontario, Kanada, M5G1X6
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Quebec
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Montreal, Quebec, Kanada, H2X 0C1
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Cheras, Malaysia, 56000
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George Town, Malaysia, 10450
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Ipoh, Malaysia, 30450
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Kuala Lumpur, Malaysia, 59100
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Kuala Lumpur, Malaysia, 50586
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Kuching, Malaysia, 93586
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Putrajaya, Malaysia, 62250
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Amersfoort, Niederlande, 3813 TZ
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Amsterdam, Niederlande, 1066 CX
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Nijmegen, Niederlande, 6525 GA
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Rotterdam, Niederlande, 3015 GD
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Tilburg, Niederlande, 5022 GC
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Utrecht, Niederlande, 3584 CX
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Bialystok, Polen, 15 027
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Biała Podlaska, Polen, 21 500
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Brzozów, Polen, 36 200
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Gdansk, Polen, 80 214
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Gliwice, Polen, 44 100
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- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polen, 93 339
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- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polen, 10 228
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Opole, Polen, 45 061
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- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Polen, 02 781
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Barrio Monacillos, Puerto Rico, 00935
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Gothenburg, Schweden, 413 45
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Lund, Schweden, 222 42
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Stockholm, Schweden, 171 76
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Stockholm, Schweden, 118 83
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Uppsala, Schweden, SE 751 85
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Barcelona, Spanien, 08041
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Barcelona, Spanien, 08035
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Madrid, Spanien, 28034
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Madrid, Spanien, 28041
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Madrid, Spanien, 28007
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Pamplona, Spanien, 31008
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Seville, Spanien, 41013
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Valencia, Spanien, 46010
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Daegu, Südkorea, 41404
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Seoul, Südkorea, 05505
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Seoul, Südkorea, 03080
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Seoul, Südkorea, 06351
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Seoul, Südkorea, 03722
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Seoul, Südkorea, 06591
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Kaohsiung City, Taiwan, 83301
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Kaohsiung City, Taiwan, 80756
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10043
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Taoyuan, Taiwan, 333
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Adana, Türkei (türkiye), 01060
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Ankara, Türkei (türkiye), 06800
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Ankara, Türkei (türkiye), 06010
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Ankara, Türkei (türkiye), 06200
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Ankara, Türkei (türkiye), 06560
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Istanbul, Türkei (türkiye), 34147
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Istanbul, Türkei (türkiye), 34899
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Konya, Türkei (türkiye), 42090
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Sakarya, Türkei (türkiye), 54290
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Budapest, Ungarn, 1082
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Eger, Ungarn, 3300
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Szeged, Ungarn, 6720
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Arizona
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Gilbert, Arizona, Vereinigte Staaten, 85234
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Arkansas
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Jonesboro, Arkansas, Vereinigte Staaten, 72401
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Los Angeles, California, Vereinigte Staaten, 90033
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New Haven, Connecticut, Vereinigte Staaten, 06519
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
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Canton, Ohio, Vereinigte Staaten, 44718
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Mayfield Heights, Ohio, Vereinigte Staaten, 44124
- Rekrutierung
- Cleveland Clinic Cancer Center Hillcrest Hospital
-
Sandusky, Ohio, Vereinigte Staaten, 44870
- Rekrutierung
- Cleveland Clinic Cancer Centers Sandusky
-
Strongsville, Ohio, Vereinigte Staaten, 44136
- Rekrutierung
- Cleveland Clinic Cancer Center Strongsville
-
Warrensville Heights, Ohio, Vereinigte Staaten, 44122
- Rekrutierung
- Cleveland Clinic Cancer Center South Pointe Hospital
-
Wooster, Ohio, Vereinigte Staaten, 44691
- Rekrutierung
- Wooster Milltown Specialty and Surgery Center
-
-
Oregon
-
Bend, Oregon, Vereinigte Staaten, 97701
- Rekrutierung
- St Charles Medical Center
-
Portland, Oregon, Vereinigte Staaten, 97239
- Rekrutierung
- Oregon Health And Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
- Rekrutierung
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Rekrutierung
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232 1301
- Rekrutierung
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Rekrutierung
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Vereinigte Staaten, 79606
- Rekrutierung
- Texas Oncology West Texas
-
Dallas, Texas, Vereinigte Staaten, 75246
- Rekrutierung
- Texas Oncology DFW
-
Dallas, Texas, Vereinigte Staaten, 75390
- Rekrutierung
- UT Southwestern
-
Houston, Texas, Vereinigte Staaten, 77030
- Rekrutierung
- MD Anderson Cancer Center
-
Round Rock, Texas, Vereinigte Staaten, 78665
- Rekrutierung
- Baylor Scott and White Health 1
-
San Antonio, Texas, Vereinigte Staaten, 78240
- Rekrutierung
- Texas Oncology - San Antonio
-
Temple, Texas, Vereinigte Staaten, 76508
- Rekrutierung
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, Vereinigte Staaten, 22201
- Rekrutierung
- Virginia Cancer Specialists
-
Fairfax, Virginia, Vereinigte Staaten, 22031
- Rekrutierung
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, Vereinigte Staaten, 23249
- Rekrutierung
- Richmond VA Medical Center
-
Richmond, Virginia, Vereinigte Staaten, 23298
- Rekrutierung
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Edmonds, Washington, Vereinigte Staaten, 98026
- Rekrutierung
- Swedish Cancer Institute Edmonds
-
Issaquah, Washington, Vereinigte Staaten, 98029
- Rekrutierung
- Swedish Cancer Institute Issaquah
-
Seattle, Washington, Vereinigte Staaten, 98104
- Rekrutierung
- Swedish Cancer Institute
-
Seattle, Washington, Vereinigte Staaten, 98109
- Rekrutierung
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Madison, Wisconsin, Vereinigte Staaten, 53705
- Rekrutierung
- William S. Middleton Memorial VA
-
-
-
-
-
Birmingham, Vereinigtes Königreich, B9 5ST
- Rekrutierung
- Birmingham Heartlands Hospital
-
Cambridge, Vereinigtes Königreich, CB2 0QQ
- Rekrutierung
- Addenbrooke's Hospital
-
Edinburgh, Vereinigtes Königreich, EH4 2XU
- Rekrutierung
- Western General Hospital
-
Hull, Vereinigtes Königreich, HU16 5JQ
- Rekrutierung
- Castle Hill Hospital
-
Leeds, Vereinigtes Königreich, LS9 7TF
- Rekrutierung
- St James University Hospital
-
London, Vereinigtes Königreich, EC1A 7BE
- Rekrutierung
- St Bartholomew's Hospital
-
London, Vereinigtes Königreich, NW1 2BU
- Rekrutierung
- University College Hospital
-
Northwood, Vereinigtes Königreich, HA6 2RN
- Rekrutierung
- Mount Vernon Cancer Centre
-
Sutton, Vereinigtes Königreich, SM2 5PT
- Rekrutierung
- Royal Marsden Hospital (Sutton)
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
- Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm A: Amivantamab in Combination With Chemotherapy
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
Amivantamab will be administered.
Andere Namen:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. |
|
Aktiver Komparator: Arm B: Cetuximab in Combination With Chemotherapy
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. Cetuximab will be administered.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Zeitfenster: Up to 4 years and 2 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. |
Up to 4 years and 2 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall Survival (OS)
Zeitfenster: Up to 7 Years 3 Months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by BICR
Zeitfenster: Up to 7 Years 3 Months
|
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by Investigator
Zeitfenster: Up to 7 Years 3 Months
|
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Progression Free Survival (PFS) as Assessed by Investigator
Zeitfenster: Up to 7 Years 3 Months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed by BICR
Zeitfenster: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed Investigator
Zeitfenster: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Response (TTR) as Assessed by BICR
Zeitfenster: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR. |
Up to 7 Years 3 Months
|
|
Time to Response as Assessed by Investigator
Zeitfenster: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator. |
Up to 7 Years 3 Months
|
|
Progression-free Survival After Subsequent Therapy (PFS2)
Zeitfenster: Up to 7 Years 3 Months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Zeitfenster: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by Investigator
Zeitfenster: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Treatment Failure
Zeitfenster: Up to 7 Years 3 Months
|
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy. |
Up to 7 Years 3 Months
|
|
Curative Resection (R0) Rate
Zeitfenster: Up to 7 Years 3 Months
|
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0. |
Up to 7 Years 3 Months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Zeitfenster: Up to 7 Years 3 Months
|
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 7 Years 3 Months
|
|
Number of Participants with Abnormalities in Laboratory Values
Zeitfenster: Up to 7 Years 3 Months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 7 Years 3 Months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Zeitfenster: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Zeitfenster: Up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom. |
Up to 7 Years 3 Months
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
Zeitfenster: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
Zeitfenster: Up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
Up to 7 Years 3 Months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Zeitfenster: Up to 7 Years 3 Months
|
The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects. |
Up to 7 Years 3 Months
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Darmerkrankungen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Darmerkrankungen
- Kolorektale Neubildungen
- Aminosäuren, Peptide und Proteine
- Proteine
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Camptothecin
- Alkaloide
- Enzyme und Coenzyme
- Antikörper, monoklonal, humanisiert
- Antikörper, monoklonal
- Antikörper
- Immunglobuline
- Immunoproteine
- Blutproteine
- Serumglobuline
- Globuline
- Koordinationskomplexe
- Pyrimidine
- Formyltetrahydrofolate
- Tetrahydrofolate
- Folsäure
- Pterins
- Pteridine
- Uracil
- Pyrimidinone
- Coenzyme
- Oxaliplatin
- Irinotecan
- Cetuximab
- Fluoruracil
- Leucovorin
- Levoleucovorin
- Amivantamab
Andere Studien-ID-Nummern
- 61186372COR3001
- 2024-513852-13-00 (Registrierungskennung: EUCT number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .