Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00861094|
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : December 18, 2015
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: cisplatin Drug: 5-FU Drug: oxaliplatin Radiation: radiation therapy Drug: Folinic Acid||Phase 2 Phase 3|
- To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic regimen) in patients with inoperable esophageal cancer. (Phase II)
- To assess the endoscopic complete response rate in patients treated with these regimens. (Phase II)
- To compare the event-free survival of patients treated with these regimens. (Phase III)
- To assess the toxicity profile of these regimens using the NCI CTC v2.0 criteria. (Phase II)
- To compare the overall survival, endoscopic complete response rate, incidence of grade 3-4 toxicities, and time to treatment failure in patients treated with these regimens. (Phase III)
- To evaluate the quality of life of these patients using EORTC QLQ-C30 (version 3) and a validated disease-specific module EORTC QLQ-OES18. (Phase III)
OUTLINE: This is a multicenter study. Patients are stratified according to histological type (adenocarcinoma or adenosquamous carcinoma vs squamous cell carcinoma), pretreatment weight loss within the past 6 months (grade 1 [< 10%] vs grade 2 [≥ 10%]), ECOG performance status (0 vs 1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (modified FOLFOX 4 regimen): Patients undergo radiotherapy 5 days a week for 5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment with chemotherapy repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (Herskovic regimen): Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV continuously over 24 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4 of weeks 1, 5, 8, and 11 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, periodically during study therapy, and then every 6 months for 1 year and annually for 3 years after completion of study therapy.
After completion of study therapy, patients are followed at 4 weeks and then every 3-6 months until disease progression.
PROJECTED ACCRUAL: A total of 97 patients will be accrued for the phase II portion of the study. A total of 169 patients will be accrued for the phase III portion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2012|
Experimental: FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
Other Name: 5-Fluorouracil
Radiation: radiation therapy
Drug: Folinic Acid
Experimental: 5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
Other Name: 5-Fluorouracil
Radiation: radiation therapy
- Percentage of patients who complete the full study treatment (Phase II) [ Time Frame: 12 weeks ]
- Endoscopic complete response rate (Phase II) [ Time Frame: 12 weeks ]
- Progression-free survival (Phase III) [ Time Frame: Until progression ]
- Safety profile as assessed by NCI CTC v2.0 (Phase II) [ Time Frame: Total duration of the trial ]
- Overall survival (Phase III) [ Time Frame: Total duration of the trial ]
- Complete response rate (Phase III) [ Time Frame: Total duration of the trial ]
- Time to treatment failure (Phase III) [ Time Frame: Total duration of the trial ]
- Incidence of grade 3-4 toxicities (Phase III) [ Time Frame: Total duration of the trial ]
- Quality of life as assessed by EORTC QLQ-C30 (version 3) and EORTC QLQ-OES18 (Phase III) [ Time Frame: Total duration of the trial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861094
|Principal Investigator:||Thierry Conroy, MD||Centre Alexis Vautrin|