Gastric Cancer Clinical Trial
Official title:
A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to
stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with
chemotherapy and giving them before surgery may shrink the tumor so that it can be removed
during surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with
combination chemotherapy followed by esophagectomy works in treating patients with locally
advanced cancer of the esophagus or gastroesophageal junction.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 2009 |
Est. primary completion date | July 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction - Surgically resectable disease (T1-3; NX, N0, or N1; M1a) - T4 tumors that are not unequivocally unresectable allowed - Celiac lymph node (stations 15-20) involvement allowed - Must be considered a potential surgical candidate by a thoracic or general surgeon - No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm) - No distant metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 - Patients with ECOG 2 must be considered good candidates for study by treating oncologists Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/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 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease Other - No uncontrolled infection - No other severe underlying disease that would preclude study participation - No grade 2 or greater peripheral neuropathy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for esophageal cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to anticipated fields of study radiotherapy Surgery - Not specified Other - No concurrent diuretics - No concurrent amifostine |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Medical X-Ray Center, PC | Sioux Falls | South Dakota |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Park Nicollet Cancer Center | St. Louis Park | Minnesota |
United States | United Hospital | St. Paul | Minnesota |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Jatoi A, Martenson J, Mahoney MR, Lair BS, Brindle JS, Nichols F, Caron N, Rowland K, Tschetter L, Alberts S. Results of a planned interim toxicity analysis with trimodality therapy, including carboplatin AUC = 4, paclitaxel, 5-fluorouracil, amifostine, a — View Citation
Jatoi A, Martenson JA, Foster NR, McLeod HL, Lair BS, Nichols F, Tschetter LK, Moore DF Jr, Fitch TR, Alberts SR; North Central Cancer Treatment Group (N0044).. Paclitaxel, carboplatin, 5-fluorouracil, and radiation for locally advanced esophageal cancer: — View Citation
Jatoi A. Aggressive multimodality therapy for patients with locally advanced esophageal cancer: is there a role for amifostine? Semin Oncol. 2003 Dec;30(6 Suppl 18):72-5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of successes | Up to 4 years | No | |
Secondary | Toxicity-free rate | Up to 4 years | Yes | |
Secondary | Clinical tumor response | Up to 4 years | No | |
Secondary | Pathologic tumor response | Up to 4 years | No | |
Secondary | Time to disease progression | Up to 4 years | No | |
Secondary | Surgical outcome | Up to 4 years | No | |
Secondary | Survival | Up to 4 years | No | |
Secondary | Time to treatment failure | Up to 4 years | No | |
Secondary | Quality of life | Up to 4 years | No |
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