Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
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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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer |
| Enrollment: | 21 |
| Study Start Date: | May 2000 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy.
- Determine the complete and partial responses in patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
- Determine the optimal dose of paclitaxel when administered in this regimen in these patients.
- Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses.
Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks.
At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy.
Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction
- Potentially resectable disease
- No malignant celiac node involvement
- No cervical esophageal carcinoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Other:
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significant medical or psychiatric illness that would preclude study
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for esophageal cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior thoracic radiotherapy
Surgery:
- See Disease Characteristics
- No prior surgical resection of esophageal tumor
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Study Chair: | Jonathan Cheng, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00021320 History of Changes |
| Other Study ID Numbers: | CDR0000068769, P30CA006927, FCCC-00003, NCI-G01-1982 |
| Study First Received: | July 11, 2001 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fox Chase Cancer Center:
|
stage 0 esophageal cancer stage I esophageal cancer stage II esophageal cancer |
stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Cisplatin Fluorouracil Paclitaxel Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013