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Status:

COMPLETED

Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer

Lead Sponsor:

UNICANCER

Conditions:

Esophageal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the g...

Detailed Description

OBJECTIVES: Primary * To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic regimen) i...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus
  • Locally advanced disease (any T, N0 or N1, M0 or M1a)
  • No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a)
  • Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed
  • No radiographic evidence of enlarged (≥ 1.5 cm) celiac lymph nodes by CT scan or echography
  • No small cell or undifferentiated carcinoma of the esophagus
  • No multiple carcinomas of the esophagus (i.e., \> 1 esophageal tumor)
  • No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III)
  • Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying \> 1 cm-5 cm above gastroesophageal junction) allowed
  • Inoperable disease OR surgery is contraindicated
  • No tracheo-esophageal fistula or invasion of the tracheo-bronchial tree
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • Creatinine \< 15 mg/L
  • Total bilirubin \< 1.5 times upper limit of normal (ULN)
  • ALT and AST \< 2.5 times ULN
  • Prothrombin time ≥ 60%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Caloric intake sufficient (i.e., \> 1,000 Kcal/m²/day) (orally or with gastrostomy)
  • No weight loss \> 20% normal body weight within the past 3 months
  • No complete dysphagia
  • No exclusive requirement for parenteral nutrition
  • No peripheral neuropathy \> grade 1
  • No sensitive peripheral neuropathy with functional impairment
  • No auditory disorders
  • No other prior malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or stage I or II node-negative head and neck cancer that was curatively treated \> 3 years ago
  • No myocardial infarction within the past 6 months
  • Patients who have had a myocardial infarction \> 6 months ago are eligible provided there is no transient ischemia by thallium myocardial scintigraphy and patient is able to undergo chemotherapy , as determined by a cardiologist
  • No other serious illness or medical condition (e.g., symptomatic coronary disease, left ventricular failure, or uncontrolled infection)
  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2012

    Estimated Enrollment :

    266 Patients enrolled

    Trial Details

    Trial ID

    NCT00861094

    Start Date

    March 1 2008

    End Date

    December 1 2012

    Last Update

    December 18 2015

    Active Locations (28)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (28 locations)

    1

    CHR de Besancon - Hopital Saint-Jacques

    Besançon, France, 25030

    2

    Hopital Saint Andre

    Bordeaux, France, 33075

    3

    Institut Bergonie

    Bordeaux, France, 33076

    4

    Hopital Ambroise Pare

    Boulogne-Billancourt, France, F-92104