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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00069953 |
Purpose
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
| Condition | Intervention | Phase |
|
Esophageal Cancer |
Drug: cisplatin Drug: filgrastim Drug: fluorouracil Drug: paclitaxel Drug: pegfilgrastim Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders |
| Drug Information available for: | Filgrastim Cisplatin Paclitaxel Fluorouracil Pegfilgrastim |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus |
| Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
Patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
No evidence of disseminated cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations![]() |
Show 97 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Stephen G. Swisher, MD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Swisher S, Winters K, Komaki R, et al.: A phase II study of a paclitaxel based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-190, S106, 2007.
  |
| Study ID Numbers: | CDR0000306455, RTOG-0246 |
| First Received: | October 3, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069953 |
| Health Authority: | United States: Federal Government |
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