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Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus Clinical research trials and Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus. Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
For Condition: stage 3 esophageal cancer,stage 2 esophageal cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GerardGanem, Study Chair, Centre Jean Bernard
Hopital Andre Mignot
Le Chesnay, , 78157
France
Hopital Saint Antoine
Paris, , 75571
France
CHR de Grenoble - La Tronche
Grenoble, , F-38043
France
Clinique Fleming
Tours, , 37000
France
Polyclinique De Courlancy
Reims, , F-51100
France
CMC Les Ormeaux
Le Havre, , 76600
France
Hopital Tenon
Paris, , 75970
France
C.H. Senlis
Senlis, , 60309
France
Hopital Saint-Louis
Amiens, , 80054 Cedex 1
France
Centre Jean Bernard
Le Mans, , 72000
France
Clinique Saint Vincent
Besancon, , 25044
France
Clinique Saint - Jean
Cagne-sur-Mer, , 06800
France
Clinique Ste - Marie
Pontoise, , 95301
France
Hopital Laennec
Paris, , 75007
France
Additional Information:
Study ID Numbers: CDR0000068368; EU-20021,FRE-GERCOR-D99-1
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008047
Other Stage 2 Esophageal Cancer Studies:
1. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
2. Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
3. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
5. Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
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Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
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