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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CCF-5848 | Other Identifier | Cleveland Clinic IRB | |
| ZENECA-1839/US/0233 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | 20mg/m2d/IV continuous infusion x days |
| |
| fluorouracil | Drug | 1000mg/m2/d IV continuous infusion x 4 days |
| |
| Iressa | Drug | 250mg po qd days 1-28 then x 2 years |
| |
| conventional surgery | Procedure | conventional surgery | ||
| radiation therapy | Radiation | 150 cGy bid |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 1 year | Survival at 1 year | 1 year |
| Distant metastatic control at 1 year | Distant metastatic control at 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate at 6 weeks | Response rate at 6 weeks | 6 weeks |
| Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks | Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction
T3, N1, or M1a disease only
The following types are not allowed:
No evidence of distant hematogenous tumor metastases (M1b)
No malignant pleural effusions
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| David J. Adelstein, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D000077156 | Gefitinib |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| 6 weeks |
| Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy | Toxicity of maintenance gefitinib as measured by CTC version 2.0 | 8 weeks |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D014498 |
| Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |