Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00008047
• Other study ID #: CDR0000068368
• Secondary ID: FRE-GERCOR-D99-1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 6, 2001
• Last updated: February 6, 2009
• Start date: August 1999

Study information

• Verified date: February 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• fluorouracil

• hydroxyurea

• paclitaxel

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Hopital Saint-Louis	Amiens
France	Clinique Saint Vincent	Besancon
France	Clinique Saint - Jean	Cagne-sur-Mer
France	CHR de Grenoble - La Tronche	Grenoble
France	Hopital Andre Mignot	Le Chesnay
France	CMC Les Ormeaux	Le Havre
France	Centre Jean Bernard	Le Mans
France	Hopital Laennec	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Clinique Ste - Marie	Pontoise
France	Polyclinique De Courlancy	Reims
France	C.H. Senlis	Senlis
France	Clinique Fleming	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France,