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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| UNICANCER | OTHER |
| SFRO:French Society of Radiation Oncology | UNKNOWN |
| Federation Francophone de Cancerologie Digestive |
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Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks, according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of patients, whereas no patients survived for 5 years using radiotherapy alone for patients with esophageal cancer. Surgery, even when combined with preoperative RCT, also gives disappointing results for locally advanced tumors, which casts serious doubts on the usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length of treatment or the radiotherapy volumes, it has become possible to obtain levels of loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional relapse according to the dose of radiation and the recommended radiotherapy volumes, we aimed to investigate why increasing the dose of radiation has no impact in esophageal cancers. Although INT-0123 phase III trial showed no benefit of dose escalation in esophageal cancer, some issues remain unclear as most of the patients who died in the experimental arm were treated above 50Gy. Moreover, only the tumor was treated up to 64Gy while involved nodes were not considered for dose escalation in this trial. In the RTOG 85-01phase III trial, an elective nodal irradiation from subclavicular fossa up to the esophagogastric junction was performed with a 2D technique, delivering 30Gy which could be considered as not appropriate.
In this randomized phase II/III trial, we aim to test an exclusive concomitant chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the RTOG) with a risk of microscopic involvement ≥ 20%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Active Comparator | Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
|
|
| ARM B | Experimental | Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node | Radiation | 40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the rate of acute toxicity leading to cessation or temporary interruption of treatment of more than a total of 14 days or of 7 consecutive days during the whole treatment. | end of phase II (january 2014) | |
| Evaluate the rate of completes endoscopic response at 3 months | for each patient 3 months after the end treatment | |
| Survival without locoregional relapse at 2 years (time elapsed between date of randomisation and onset of local relapse and/or lymph node involvement) | after the end of phase III in january 2015 (anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate adherence | every 3 months until the end of phase II (january 2014) | |
| Evaluate acute toxicity at 3 months | for each patient 3 months after the end treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Créhange, MD | Centre Georges Francois Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26228970 | Derived | Bednarek C, Crehange G, Quivrin M, Cueff A, Vulquin N, Chevalier C, Cerda T, Petegnief Y, Mazoyer F, Maingon P, Bosset JF, Servagi Vernat S. Mapping of failures after radiochemotherapy in patients with non-metastatic esophageal cancer: A posteriori analysis of the dose distribution in the sites of loco-regional relapse. Radiother Oncol. 2015 Aug;116(2):252-6. doi: 10.1016/j.radonc.2015.07.019. Epub 2015 Jul 27. |
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| OTHER |
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| Boost | Radiation | Boost 10 Gy in 5 fr, PTV = +1cm. |
|
| Boost | Radiation | Boost 26 Gy in 13 fr, PTV = +1cm. |
|
| chemotherapy: FOLFOX 4 | Drug | 6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43) arm B or 3 courses concomitant to radiotherapy (D1, D15, D29) arm A. |
|
| Evaluate death due to toxicity |
| each month during all the study |
| Evaluate quality of life (QLQ-C30 [annex n° 2] + OG25 [annex n° 3]) | after the completion of phase II (january 2014) |
| Compare according to treatment arm :Quality of life (QLQ-C30 [annex n° 2] + OG 25 [annex n° 3]) | after the completion of phase III (january 2015-anticpated) |
| Compare according to treatment arm :Overall survival | after the completion of phase III (january 2015-anticpated) |
| Compare according to treatment arm :Disease-free survival | after the completion of phase III (january 2015-anticpated) |
| Compare according to treatment arm :Acute and late toxicity according to the CTCAE version 3.0 scale | after the completion of phase III (january 2015-anticpated) |
| Compare according to treatment arm :The number of palliative interventions, the time to the first palliative intervention | after the completion of phase III (january 2015-anticpated) |
| Compare according to treatment arm :The rate of dysphagia according to Atkinson's criteria | after the completion of phase III (january 2015-anticipated) |
| Compare according to treatment arm :Survival without local recurrence in responders | after the completion of phase III (january 2015-anticipated) |
| Compare according to treatment arm :Progression-free survival in non-responding patients | after the completion of phase III (january 2015-anticipated) |
| Evaluation of the post-operative morbi-mortalities | Evaluation of the post-operative morbi-mortalities (in 30 days) of the group of patients which will benefit from of a surgery of the tumoral residue. | after the completion of phase III (january 2015-anticipated) |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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