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Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus - Article


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Gastrointestinal



Clinical Trial: Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

This study is no longer recruiting patients.

Sponsored by: Hopital Jules Courmont - Centre Hospitalier Lyon Sud
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether external-beam radiation therapy plus chemotherapy is more effective with or without internal radiation therapy. PURPOSE: Randomized phase III trial to compare chemotherapy and external-beam radiation therapy with or without internal radiation therapy in treating patients with stage I, stage II, or stage III esophageal cancer.

Condition Treatment or Intervention Phase
childhood gastrointestinal cancer
stage III esophageal cancer
Adenocarcinoma of the Esophagus
stage I esophageal cancer
stage II esophageal cancer
squamous cell carcinoma of the esophagus
 Drug: cisplatin
 Drug: fluorouracil
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Digestive Diseases;   Esophageal Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Chemoradiotherapy With or Without High Dose Brachytherapy for Patients With Unresectable Stage I, II, or III Esophageal Cancer

Further Study Details: 

Study start: March 1996

OBJECTIVES: I. Compare the complete local remission rate in patients with unresectable stage I, II, or III esophageal cancer treated with chemoradiotherapy with or without endoluminal brachytherapy. II. Compare the complete remission rate (local, locoregional, and distant) in these patients. III. Compare the overall and disease free survival in these patients at 2 and 5 years after therapy. IV. Compare the toxicity and quality of life experienced by these patients.

PROTOCOL OUTLINE: This study is randomized for brachytherapy following external beam radiotherapy and current chemotherapy. Patients are stratified by randomizing center, tumor stage and platelet count. All patients receive fluorouracil by continuous intravenous infusion over 4 days (days 1-4) and/or cisplatin on day 2 of weeks 1 and 5. External beam radiotherapy begins on day 1 of chemotherapy and is delivered in daily fractions, 5 days per week, for 5 weeks, followed by a cone down dose administered during week 6. Patients randomized to brachytherapy (Iridium 192, high dose rate) are treated on weeks 11 and 12, and receive 2 additional courses of chemotherapy at weeks 9 and 14. Patients randomized to no brachytherapy receive additional chemotherapy courses on weeks 9 and 13. Chemotherapy is adapted to the platelet count. Patients are followed every 6 months until 2 years past entry, then annually until 5 years past entry.

PROJECTED ACCRUAL: A total of 326 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  up to  74 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus; No cancer of the cardia
  • Stage T1, T2, or T3; No T3 tumor greater than 7 cm; No involved nodes located more than 3 cm from tumor; Supraclavicular nodal involvement eligible with cervical esophageal tumor; No metastasis
  • Patient ineligible for surgery because of either of the following: Condition that contraindicates surgery; Refusal of surgery
  • No ulceration or stenosis requiring dilatation at initiation of treatment

--Prior/Concurrent Therapy--

  • No prior laser therapy; No prior electrocoagulation; No prior cryotherapy; No prior sclerosing injection

--Patient Characteristics--

  • Age: Under 75
  • Performance status: 0-2
  • Hematopoietic: WBC at least 2,000/mm3; Polymorphonuclear lymphocyte count at least 1,500/mm3; Platelet count at least 80,000/mm3 at selection (at least 40,000 at randomization); Hemoglobin at least 10 g/dL
  • Hepatic: Not specified
  • Renal: Creatinine less than 1.2 mg/dL (110 micromoles/L); Creatinine clearance at least 60 mL/min in patients over age 60
  • Cardiovascular: No angina pectoris; No history of myocardial infarction; No contraindication to therapy on EKG; No other cardiac contraindication to chemotherapy
  • Other: No peripheral neuropathy; No second malignancy except: Basal cell carcinoma of the skin; Carcinoma in situ of the uterine cervix; ORL carcinoma with remission for at least 2 years; Not pregnant or nursing; Adequate contraception required of fertile women

Location Information


France
      Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre-Benite,  69495,  France

Study chairs or principal investigators

Jean Pierre Gerard,  Study Chair,  Hopital Jules Courmont - Centre Hospitalier Lyon Sud   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065193; FRE-CURIE-HDD; EU-96013
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002884
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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Page Updated: December 9, 2005
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