Gastric Cancer Clinical Trial
Official title:
Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.
Status | Completed |
Enrollment | 97 |
Est. completion date | October 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction - Stage T2-3, N0, M0 OR - Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis) - Tumor must be considered surgically resectable (T1-3, but not T4) - Age>=18 years - ECOG Performance status 0-1 - Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization: - Granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years - Fertile patients must use effective contraception - Endoscopy with biopsy and dilation allowed Exclusion Criteria: - Tumor extends more than 2 cm into the cardia - Pregnant or nursing - Other concurrent illness that would preclude study therapy or surgical resection - Concurrent filgrastim (G-CSF) during study radiotherapy - Prior chemotherapy - Prior radiotherapy - Prior surgery |
Country | Name | City | State |
---|---|---|---|
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio |
United States | CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | Shands Cancer Center at the University of Florida Health Science Center | Gainesville | Florida |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | St. Joseph's Hospital | Saint Paul | Minnesota |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States,
Kleinberg L, Powell ME, Forastiere AA, et al.: Survival outcome of E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/radiotherapy (RT) or irinotecan/cisplatin/RT in endoscopy wit
Kleinberg LR, Eapen S, Hamilton S, et al.: E1201: an Eastern Cooperative Oncology Group (ECOG) randomized phase II trial to measure response rate and toxicity of preoperative combined modality paclitaxel/cisplatin/RT or irinotecan/cisplatin/RT in adenocar
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic Complete Response Rate | A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue. | approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | |
Secondary | Overall Survival Time | Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients. | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | |
Secondary | Recurrence-free Survival Time | Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients. | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry |
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