- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00268437
Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
OBJECTIVES:
Primary
* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.
Secondary
- Determine the activity, in terms of clinical response rate and adverse event profile of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy.
- Determine the overall survival, time-to-progression, and time-to-treatment failure for patients receiving the above combined modality treatment.
- Determine the surgical outcome for all patients who undergo esophagectomy.
- Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection.
- Determine quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy.
Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery.
After completion of study treatment, patients are followed periodically for approximately 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Arizona
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Scottsdale, Arizona, Vereinigte Staaten, 85259-5499
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, Vereinigte Staaten, 60507
- Rush-Copley Cancer Care Center
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Canton, Illinois, Vereinigte Staaten, 61520
- Graham Hospital
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Carthage, Illinois, Vereinigte Staaten, 62321
- Memorial Hospital
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Effingham, Illinois, Vereinigte Staaten, 62401
- St. Anthony's Memorial Hospital
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Eureka, Illinois, Vereinigte Staaten, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Vereinigte Staaten, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Vereinigte Staaten, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, Vereinigte Staaten, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Vereinigte Staaten, 62644
- Mason District Hospital
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Hopedale, Illinois, Vereinigte Staaten, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Vereinigte Staaten, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Kewanee, Illinois, Vereinigte Staaten, 61443
- Kewanee Hospital
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Macomb, Illinois, Vereinigte Staaten, 61455
- Mcdonough District Hospital
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Normal, Illinois, Vereinigte Staaten, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Vereinigte Staaten, 61761
- Community Cancer Center
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Vereinigte Staaten, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Vereinigte Staaten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Vereinigte Staaten, 61614
- Proctor Hospital
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Peoria, Illinois, Vereinigte Staaten, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Vereinigte Staaten, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Vereinigte Staaten, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Vereinigte Staaten, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Vereinigte Staaten, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Vereinigte Staaten, 61362
- Valley Cancer Center
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Urbana, Illinois, Vereinigte Staaten, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Vereinigte Staaten, 61801
- CCOP - Carle Cancer Center
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Indiana
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Michigan City, Indiana, Vereinigte Staaten, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403
- Cedar Rapids Oncology Associates
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Des Moines, Iowa, Vereinigte Staaten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Vereinigte Staaten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Vereinigte Staaten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Vereinigte Staaten, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Vereinigte Staaten, 50307
- Mercy Capitol Hospital
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Sioux City, Iowa, Vereinigte Staaten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Vereinigte Staaten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Vereinigte Staaten, 51104
- Mercy Medical Center - Sioux City
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Vereinigte Staaten, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Vereinigte Staaten, 48503
- Hurley Medical Center
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Flint, Michigan, Vereinigte Staaten, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Vereinigte Staaten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Vereinigte Staaten, 49201
- Foote Hospital
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Lansing, Michigan, Vereinigte Staaten, 48912-1811
- Sparrow Regional Cancer Center
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Saginaw, Michigan, Vereinigte Staaten, 48601
- Seton Cancer Institute - Saginaw
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Warren, Michigan, Vereinigte Staaten, 48093
- St. John Macomb Hospital
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Minnesota
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Albert Lea, Minnesota, Vereinigte Staaten, 56007
- Albert Lea Cancer Center at Albert Lea Medical Center
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Burnsville, Minnesota, Vereinigte Staaten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Vereinigte Staaten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Vereinigte Staaten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Vereinigte Staaten, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Vereinigte Staaten, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Vereinigte Staaten, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Vereinigte Staaten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Vereinigte Staaten, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Vereinigte Staaten, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Vereinigte Staaten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Vereinigte Staaten, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St Paul, Minnesota, Vereinigte Staaten, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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St. Louis Park, Minnesota, Vereinigte Staaten, 55416
- Park Nicollet Cancer Center
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St. Paul, Minnesota, Vereinigte Staaten, 55102
- United Hospital
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St. Paul, Minnesota, Vereinigte Staaten, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Vereinigte Staaten, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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North Carolina
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Rutherfordton, North Carolina, Vereinigte Staaten, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Vereinigte Staaten, 58502
- St. Alexius Medical Center Cancer Center
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Ohio
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Dayton, Ohio, Vereinigte Staaten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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South Carolina
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Anderson, South Carolina, Vereinigte Staaten, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
- No T1-2, N0, M0 disease
No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction
+ Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions
- Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction
- No evidence of distant metastases
Tumor must be considered surgically resectable
- Patients with T4, N0 tumors that are potentially resectable are eligible
- No clinically relevant pleural or peritoneal effusion that is not amenable to drainage
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥1,500/mm^3
- Platelet count ≥100,000/mm^3
- Hemoglobin ≥10 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Creatinine clearance ≥ 45 mL/min
- No New York Heart Association class III or IV congestive heart failure
- Pregnant or nursing women are ineligible
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No other severe underlying disease that would preclude study entry
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
- No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin
- Able to swallow pills
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for esophageal cancer
- No prior radiotherapy field that overlapped the anticipated fields of study radiotherapy
- No prior radiotherapy to > 30% of the marrow cavity
- Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to discontinue use 2 days prior, during, and 2 days after pemetrexed disodium administration (5 days prior for long-life NSAIDs)
- Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and while receiving protocol therapy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
|
carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Pathologic Complete Response Rate
Zeitfenster: Baseline to time of surgery (around 10 - 18 weeks post-baseline)
|
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients.
Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT.
Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung.
However, CT is preferable.
|
Baseline to time of surgery (around 10 - 18 weeks post-baseline)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival
Zeitfenster: From baseline to 4 years
|
Time from registration to death due to any cause.
|
From baseline to 4 years
|
Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Jatoi A, Soori G, Foster NR, Hiatt BK, Knost JA, Fitch TR, Callister MD, Nichols FC 3rd, Husted TM, Alberts SR. Phase II study of preoperative pemetrexed, carboplatin, and radiation followed by surgery for locally advanced esophageal cancer and gastroesophageal junction tumors. J Thorac Oncol. 2010 Dec;5(12):1994-8. doi: 10.1097/JTO.0b013e3181fb5c3e.
- Katipamula R, Jatoi A, Foster NR, Nichols F, Rubin J, Callister M, Gunderson L, Alberts S. Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E. Clin Med Oncol. 2008;2:223-5. doi: 10.4137/cmo.s444. Epub 2008 Apr 1.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Ösophagusneoplasmen
- Molekulare Mechanismen der pharmakologischen Wirkung
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Folsäure-Antagonisten
- Carboplatin
- Pemetrexed
Andere Studien-ID-Nummern
- NCCTG-N044E
- NCI-2012-02678 (Registrierungskennung: CTRP (Clinical Trials Reporting System))
- CDR0000455635 (Registrierungskennung: PDQ (Physician Data Query))
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 .
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