Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-06

Study Completion Date

2018-12-17

Brief Summary

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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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Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM A

Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:

1. Radiotherapy 40 Gy, in 20 fractions / 4 weeks: PTV (1cm in every direction)
2. Boost 10 Gy in 5 fr: PTV = +1cm.
3. Chemotherapy FOLFOX 4: 6 treatments in 3 courses concomitant to the radiotherapy (D1, D15, D29)

Group Type ACTIVE_COMPARATOR

Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node

Intervention Type RADIATION

40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)

Boost

Intervention Type RADIATION

Boost 10 Gy in 5 fr, PTV = +1cm.

chemotherapy: FOLFOX 4

Intervention Type 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.

ARM B

Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph nodes:

1. 40 Gy in 20 fractions / 4 weeks, PTV (1cm in every direction)
2. Boost 26 Gy in 13 fr: PTV = +1cm.
3. Chemotherapy: FOLFOX 4: 6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43).

Group Type EXPERIMENTAL

Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node

Intervention Type RADIATION

40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)

Boost

Intervention Type RADIATION

Boost 26 Gy in 13 fr, PTV = +1cm.

chemotherapy: FOLFOX 4

Intervention Type 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.

Interventions

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Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node

40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)

Intervention Type RADIATION

Boost

Boost 10 Gy in 5 fr, PTV = +1cm.

Intervention Type RADIATION

Boost

Boost 26 Gy in 13 fr, PTV = +1cm.

Intervention Type RADIATION

chemotherapy: FOLFOX 4

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age\> or = 18 and \< 75 ans
2. WHO Status 0, 1 and 2
3. Enteral or parenteral feeding (\> or = 1500 KCal) planned before the start of treatment
4. Histologically proven carcinoma of the oesophagus
5. Histological Types: adenocarcinomas and epidermoid carcinomas
6. T3, N0-N1-N2-N3, M0 (TNM version 7)
7. T1-T2, N0-N1-N2-N3, M0 with a contra-indication for surgery (TNM version 7)
8. Absence of trachea-oesophageal fistula
9. Written informed consent
10. Woman under appropriate contraception
11. Patient able to understand and complete, with help if necessary, a quality of life questionnaire

Exclusion Criteria

1. Evolutive heart failure or myocardial necrosis for less than 6 months
2. Myocardial infarction of more than 6 months with ischemic sequelae on myocardial scintigraphy.
3. Patient cannot absorb at least 1500kcal/j before and/or during treatment
4. Left heart failure.
5. Stage II to IV arteriopathy in the Leriche and Fontaine classification
6. Creatinine \> or = 1.25x N
7. PNN \< 1,5.109 /l
8. Platelets \< 100. 109 /l
9. Albumin \< 30g/l
10. TP \< 60% without anticoagulant
11. VEMS \< 1l
12. History of cancer (except baso-cellular cutaneous epithelioma or in situ epithelioma of the cervix) that has relapsed in the 5 years preceding recruitment for the trial
13. Patient already enrolled in another therapeutic trial with an experimental molecule
14. Women who are pregnant or likely to be so, or who are breastfeeding
15. People who are in custody or under guardianship
16. Impossibility to adhere to the medical follow up for the trial for geographical,social or psychiatric reasons.
17. Presence of a history of radiotherapy to the chest or upper abdomen for another tumour
18. Peripheral neuropathy \> or = grade 1 (CTC v3.0)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No