A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT00123318|
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : June 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: epirubicin Drug: cisplatin Drug: 5-fluorouracil Radiation: Radiotherapy||Phase 3|
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques.
The specific objectives of the study are:
- To detail the acute toxicity associated with this treatment.
- To determine the feasibility of the proposed concurrent chemoradiation regimen.
- To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
50mg/m2 IV day 1
Other Name: Epirubicin Ebewe, Epirubicin Hydrochloride for Injection
60mg/m2 IV day 1
Other Name: Cisplatin Ebewe, Cisplatin Injection
5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Other Name: DBL Fluoruracil Injection BP, Efudix
45Gy 25 Fractions, 5 days/week for 5 weeks
Other Name: Radiation
- The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity [ Time Frame: Final analysis will be at 3 years. ]
- The percentage of patients who complete the planned chemoradiation protocol [ Time Frame: Final analysis will be at 3 years. ]
- The percentage of major radiotherapy protocol violations [ Time Frame: Final analysis will be at 3 years. ]
- Median survival and overall survival at 3 years [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123318
|Study Chair:||Trevor Leong||Peter MacCallum Cancer Centre, Australia|