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Prodige 26: Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Prodige 26: Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

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

4. Histologically proven carcinoma of the oesophagus

5. Histological Types: adenocarcinomas and epidermoid carcinomas

6. T3, N0-N1-N2-N3, M0 ou M1a

7. T1-T2, N0-N1-N2-N3, M0 or M1a with a contra-indication for surgery

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

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

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%

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

18. Peripheral neuropathy > or = grade 1 (CTC v3.0)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

end of phase II (january 2014)

Safety Issue:


Principal Investigator

Gilles Créhange, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Georges Francois Leclerc


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2011

Completion Date:

December 2014

Related Keywords:

  • Esophageal Cancer
  • unoperated cancers
  • oesophagus
  • radiochemotherapy
  • with and without increased doses
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms