Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00069953
First received: October 3, 2003
Last updated: April 23, 2011
Last verified: February 2006
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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 |
Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Cisplatin
Paclitaxel
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Pegfilgrastim
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival rate at 1 year [ Designated as safety issue: No ]
- Frequency of major (grade 4) acute toxicities [ Designated as safety issue: Yes ]
- Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection [ Designated as safety issue: No ]
| Study Start Date: | September 2003 |
OBJECTIVES:
- Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the treatment-related toxicity of this regimen in these patients.
- Determine the tolerance to surgical salvage in patients treated with this regimen.
- Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.
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 |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- Primary (non-recurrent) disease
- Amenable to resection
- Stage greater than T1, N0 by endoscopic ultrasound
- Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue
- Tumor may not extend more than 2 cm into the stomach
- No multiple primary carcinomas of the esophagus
- No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
No evidence of disseminated cancer
- Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies
- Palpable supraclavicular nodes must be negative for cancer by biopsy
- Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
- No celiac adenopathy greater than 2 cm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Not specified
Renal
- Creatinine no greater than 1.5 mg/dL AND/OR
- Creatinine clearance at least 65 mL/min
- Calcium no greater than 11 mg/dL
Cardiovascular
- No uncontrolled heart disease
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to comprehend study requirements and considered likely to comply with study parameters
- No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix
- No uncontrolled diabetes
- No hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 5 years since prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior chest or upper abdomen radiotherapy
Surgery
- No prior esophageal or gastric surgery
Other
- No concurrent photodynamic therapy
- No other concurrent investigational agents for esophageal carcinoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069953
Show 97 Study Locations
Show 97 Study LocationsSponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Study Chair: | Stephen G. Swisher, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00069953 History of Changes |
| Other Study ID Numbers: | CDR0000306455, RTOG-0246 |
| Study First Received: | October 3, 2003 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer |
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 Lenograstim 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 Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013