- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00109850
S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
- Determine the time to progression in patients with measurable disease treated with this regimen.
- Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)
OUTLINE: This is a multicenter study.
Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).
After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Alabama
-
Mobile, Alabama, Forente stater, 36652-2144
- Mobile Infirmary Medical Center
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Berkeley, California, Forente stater, 94704
- Alta Bates Comprehensive Cancer Center
-
Burbank, California, Forente stater, 91505
- Providence Saint Joseph Medical Center - Burbank
-
Burlingame, California, Forente stater, 94010
- Peninsula Medical Center
-
Castro Valley, California, Forente stater, 94546
- Eden Medical Center
-
Greenbrae, California, Forente stater, 94904
- Marin Cancer Institute at Marin General Hospital
-
Greenbrae, California, Forente stater, 94904
- Sutter Health - Western Division Cancer Research Group
-
Hayward, California, Forente stater, 94545
- Saint Rose Hospital
-
Los Angeles, California, Forente stater, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
-
Oakland, California, Forente stater, 94609
- Alta Bates Summit Medical Center - Summit Campus
-
Oakland, California, Forente stater, 94602
- Highland General Hospital
-
Oakland, California, Forente stater, 94609
- CCOP - Bay Area Tumor Institute
-
Palm Springs, California, Forente stater, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
-
Pleasanton, California, Forente stater, 94588
- Valley Care Medical Center
-
Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
-
San Francisco, California, Forente stater, 94118
- California Pacific Medical Center - California Campus
-
San Pablo, California, Forente stater, 94806
- Doctors Medical Center - San Pablo Campus
-
Sana Rosa, California, Forente stater, 95405
- CCOP - Santa Rosa Memorial Hospital
-
Vallejo, California, Forente stater, 94589
- Sutter Solano Medical Center
-
-
Colorado
-
Fort Collins, Colorado, Forente stater, 80524
- Poudre Valley Hospital
-
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Florida
-
Lakeland, Florida, Forente stater, 33804-5000
- Watson Clinic, LLC
-
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Georgia
-
Augusta, Georgia, Forente stater, 30901
- Augusta Oncology Associates - Walton Way
-
Savannah, Georgia, Forente stater, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
Savannah, Georgia, Forente stater, 31405
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
-
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Idaho
-
Boise, Idaho, Forente stater, 83712
- St. Luke's Mountain States Tumor Institute - Boise
-
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Illinois
-
Springfield, Illinois, Forente stater, 62781-0001
- Regional Cancer Center at Memorial Medical Center
-
-
Indiana
-
Beech Grove, Indiana, Forente stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Richmond, Indiana, Forente stater, 47374
- Reid Hospital & Health Care Services, Incorporated
-
-
Kansas
-
Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kansas City, Kansas, Forente stater, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
-
Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, Forente stater, 67901
- Southwest Medical Center
-
Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - Salina
-
Salina, Kansas, Forente stater, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
-
Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
-
Wichita, Kansas, Forente stater, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Forente stater, 67214
- CCOP - Wichita
-
Wichita, Kansas, Forente stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109-0942
- University of Michigan Comprehensive Cancer Center
-
Battle Creek, Michigan, Forente stater, 49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids, Michigan, Forente stater, 49307
- Mecosta County Medical Center
-
Detroit, Michigan, Forente stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
-
Grand Rapids, Michigan, Forente stater, 49503
- CCOP - Grand Rapids
-
Grand Rapids, Michigan, Forente stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Grand Rapids, Michigan, Forente stater, 49506
- Metro Health Hospital
-
Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health Hospital - Butterworth Campus
-
Holland, Michigan, Forente stater, 49423
- Holland Community Hospital
-
Muskegon, Michigan, Forente stater, 49442
- Hackley Hospital
-
Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forente stater, 63110
- Saint Louis University Cancer Center
-
Springfield, Missouri, Forente stater, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Forente stater, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Forente stater, 65807
- Hulston Cancer Center at Cox Medical Center South
-
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Montana
-
Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Forente stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, Forente stater, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Forente stater, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Forente stater, 59107-7000
- Billings Clinic - Downtown
-
Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Forente stater, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Forente stater, 59405
-
Helena, Montana, Forente stater, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Forente stater, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Forente stater, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Forente stater, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, Forente stater, 59801
- Community Medical Center
-
Missoula, Montana, Forente stater, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Forente stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Forente stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
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Nebraska
-
Kearney, Nebraska, Forente stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
-
New York
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, Forente stater, 14623
- Interlakes Oncology/Hematology PC
-
-
North Carolina
-
Goldsboro, North Carolina, Forente stater, 27534
- Wayne Memorial Hospital, Incorporated
-
-
Ohio
-
Akron, Ohio, Forente stater, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Dayton, Ohio, Forente stater, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forente stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forente stater, 45429
- CCOP - Dayton
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Medical Associates
-
Kettering, Ohio, Forente stater, 45429
- Charles F. Kettering Memorial Hospital
-
Middletown, Ohio, Forente stater, 45044
- Middletown Regional Hospital
-
Troy, Ohio, Forente stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Xenia, Ohio, Forente stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
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Oregon
-
Gresham, Oregon, Forente stater, 97030
- Legacy Mount Hood Medical Center
-
Milwaukie, Oregon, Forente stater, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Forente stater, 97227
- Northwest Cancer Specialists at Rose Quarter Cancer Center
-
Portland, Oregon, Forente stater, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forente stater, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Forente stater, 97210
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
-
Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Portland, Oregon, Forente stater, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Salem, Oregon, Forente stater, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
Tualatin, Oregon, Forente stater, 97062
- Legacy Meridian Park Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Charleston, South Carolina, Forente stater, 29401
- Roper St. Francis Cancer Center at Roper Hospital
-
Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
-
-
Tennessee
-
Kingsport, Tennessee, Forente stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
Knoxville, Tennessee, Forente stater, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
-
Virginia
-
Danville, Virginia, Forente stater, 24541
- Danville Regional Medical Center
-
Norton, Virginia, Forente stater, 24273
- Southwest Virginia Regional Cancer Center
-
-
Washington
-
Bellingham, Washington, Forente stater, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Forente stater, 98310
- Olympic Hematology and Oncology
-
Kennewick, Washington, Forente stater, 99336
- Columbia Basin Hematology
-
Mt. Vernon, Washington, Forente stater, 98273
- Skagit Valley Hospital Cancer Care Center
-
Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forente stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forente stater, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Forente stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forente stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Forente stater, 98122
- Polyclinic First Hill
-
Seattle, Washington, Forente stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forente stater, 99202
- Cancer Care Northwest - Spokane South
-
Vancouver, Washington, Forente stater, 98684
- Northwest Cancer Specialists at Vancouver Cancer Center
-
Vancouver, Washington, Forente stater, 98668
- Southwest Washington Medical Center Cancer Center
-
Wenatchee, Washington, Forente stater, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wyoming
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
- Disease confined to the esophagus or peri-esophageal soft tissue
- T4, M0 disease
- Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease
NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks
- Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
- Tumor specimens available
- No recurrent disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- White Blood Cell (WBC) count ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
Hepatic
- Albumin normal
- Bilirubin normal
- Alkaline phosphatase normal
- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal
Renal
- Creatinine clearance > 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior severe reaction to monoclonal antibodies
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for esophageal cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for esophageal cancer
- No concurrent intensity modulated radiotherapy
- No concurrent cobalt-60
Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
|
400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only.
250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
Andre navn:
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Andre navn:
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Andre navn:
The total dose to the prescription point will be 5,040 cGy given in 28 fractions.
The patient will be treated with one fraction per day with all fields treated per day.
180 cGy will be delivered to the isocenter.
The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival at 2 Years
Tidsramme: 0-2 years
|
Measured from time of registration to date of death due to any cause, or last contact date
|
0-2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Tidsramme: Patients were assessed for adverse events after every two cycles of chemotherapy.
|
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
For each patient, worst grade of each event type is reported.
Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
|
Patients were assessed for adverse events after every two cycles of chemotherapy.
|
|
Objective Response (Confirmed and Unconfined, Complete and Partial)
Tidsramme: at week 16, then every 3 months until progression
|
Complete response (CR) is complete disappearance of all measurable and non-measurable disease.
No new lesions.
No disease related symptoms.
Normalization of markers and other abnormal lab values.
Partial response (PR) applies only to patients with at least one measurable lesion.
Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
No unequivocal progression of non-measurable disease.
No new lesions.
Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
|
at week 16, then every 3 months until progression
|
|
Progression Free Survival
Tidsramme: 0 - 5 years
|
Measured from date of registration to date of first observation of progression or symptomatic deterioration.
Patients last known to be alive and progression-free are censored at date of last contact.
|
0 - 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
- Studiestol: Charles R. Thomas, MD, OHSU Knight Cancer Institute
- Studiestol: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
- Studiestol: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Neoplasmer i spiserøret
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerasehemmere
- Antineoplastiske midler, immunologiske
- Topoisomerase I-hemmere
- Cisplatin
- Irinotekan
- Cetuximab
Andre studie-ID-numre
- CDR0000426442
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- S0414 (Annen identifikator: SWOG)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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