Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
unoperated cancers, oesophagus, radiochemotherapy, with and without increased doses
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node Type: Radiation
Name: Boost Type: Radiation
Name: Boost Type: Radiation
Name: chemotherapy: FOLFOX 4 Type: Drug
Overall Status
Recruiting
Summary
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%.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Location
Centre Georges François Leclerc
Dijon, France
Status: Recruiting
Contact: Gilles CREHANGE, MD - 3 80 73 75 18 - gcrehange@cgfl.fr
Start Date
March 2011
Sponsors
Centre Georges Francois Leclerc
Source
Centre Georges Francois Leclerc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page