Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus
18 Years
80 Years
Both
Esophageal Cancer
Trial Information
Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus
OBJECTIVES:
- Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with
or without paclitaxel in terms of survival without dysphagia in patients with
inoperable stage II or III epidermoid carcinoma of the esophagus.
- Compare the overall survival, response rate, toxicity, and quality of life in this
patient population treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to weight loss (less than 10% vs at least 10%) and inoperability criteria
(nonresectable vs due to anatomical terrain). Patients are randomized to one of two
treatment arms.
- Arm I: Patients receive fluorouracil IV continuously, oral hydroxyurea, and concurrent
radiotherapy daily on days 1-5.
- Arm II: Patients receive fluorouracil, hydroxyurea and radiotherapy as in arm I.
Patients also receive paclitaxel IV on day 1.
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.
Patients with possible resectable disease undergo surgical resection at 4-6 weeks following
the last course of chemoradiotherapy. Patients with continued unresectable disease receive 2
additional courses of chemoradiotherapy as above within 8-17 days following the last course
of chemoradiotherapy.
Quality of life is assessed at baseline, monthly during therapy, every 2 months for 6
months, every 4 months for 1 year, and then every 6 months thereafter.
Patients are followed every 2 months for 6 months, every 4 months for 1 year, and then every
6 months thereafter.
PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage II (T2 or T3, N0, M0) or III (T3, N1, M0) epidermoid
carcinoma of the esophagus
- Inoperable due to initial extension or inoperable with no extension
- No visceral metastases
- No extension to the tracheo-bronchial pathway
- No tracheo-esophageal fistula
- No broncho-esophageal fistula
- No suspected respiratory mucosal involvement on bronchoscopy
- No carcinoma in situ
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 120,000/mm^3
- Hemoglobin at least 10 g/dL
- Neutrophil count at least 1,500/mm^3
- Lymphocyte count at least 1,000/mm^3
Hepatic:
- SGOT and SGPT no greater than 2 times normal
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Calcium less than 11.2 mg/dL
Pulmonary:
- See Disease Characteristics
- No severe respiratory illness (e.g., severe broncho-pathway obstruction or
insufficient respiration)
- No uncontrolled broncho-pulmonary infection
Other:
- No other prior history of malignancy except curatively treated carcinoma in situ of
the colon or skin cancer
- No contraindication to fluorouracil
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No psychiatric illness
- HIV negative
- Total protein at least 65% of normal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent participation in other study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Gerard Ganem, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Jean Bernard
Authority:
United States: Federal Government
Study ID:
CDR0000068368
NCT ID:
NCT00008047
Start Date:
August 1999
Completion Date:
Related Keywords:
- Esophageal Cancer
- stage II esophageal cancer
- stage III esophageal cancer
- Carcinoma, Squamous Cell
- Esophageal Diseases
- Esophageal Neoplasms
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