Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer
NCT ID: NCT00861094
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
266 participants
INTERVENTIONAL
2008-03-31
2012-12-31
Brief Summary
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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.
Detailed Description
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Primary
* 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)
Secondary
* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
5-FU
oxaliplatin
radiation therapy
Folinic Acid
5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
cisplatin
5-FU
radiation therapy
Interventions
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cisplatin
5-FU
oxaliplatin
radiation therapy
Folinic Acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No stage II-IV arterial disease, according to the DE LERICHE and FONTAINE classification
* No geographical, social, or psychological circumstances preventing regular follow-up
PRIOR CONCURRENT THERAPY:
* No prior treatment for esophageal cancer (e.g., surgery, chemotherapy, or radiotherapy)
* No prior cervical, thoracic, or abdominal radiotherapy with field overlapping the proposed esophageal radiotherapy field
* More than 30 days since prior experimental drugs or participation in another clinical trial
* No other concurrent anticancer therapy
* No concurrent phenytoin or yellow fever vaccine
* No concurrent high-dose, long-term corticosteroids
* No concurrent calcium gluconate/magnesium sulfate infusions
* No concurrent hematopoietic growth factors
* No concurrent esophageal dilatation
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Thierry Conroy, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Alexis Vautrin
Locations
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CHR de Besancon - Hopital Saint-Jacques
Besançon, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Polyclinique Du Parc
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Hopital Du Bocage
Dijon, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Tenon
Paris, , France
CHU Poitiers
Poitiers, , France
Institut Jean Godinot
Reims, , France
CHU - Robert Debre
Reims, , France
Centre Eugene Marquis
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Du Parc
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Winter A, Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial. Qual Life Res. 2023 Mar;32(3):669-679. doi: 10.1007/s11136-022-03252-6. Epub 2022 Sep 17.
Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Joint modelling with competing risks of dropout for longitudinal analysis of health-related quality of life in cancer clinical trials. Qual Life Res. 2022 May;31(5):1359-1370. doi: 10.1007/s11136-021-03040-8. Epub 2021 Nov 24.
Cuer B, Mollevi C, Anota A, Charton E, Juzyna B, Conroy T, Touraine C. Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17. BMC Med Res Methodol. 2020 Sep 3;20(1):223. doi: 10.1186/s12874-020-01104-w.
Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18.
Other Identifiers
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FRE-FNCLCC- ACCORD-17-0707
Identifier Type: -
Identifier Source: secondary_id
EU-20848
Identifier Type: -
Identifier Source: secondary_id
CDR0000595050
Identifier Type: -
Identifier Source: org_study_id