Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA)
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|ClinicalTrials.gov Identifier: NCT03817268|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Capecitabine monotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||768 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||January 16, 2026|
|Estimated Study Completion Date :||January 30, 2026|
|Experimental: Capecitabine monotherapy group||
Drug: Capecitabine monotherapy
Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.
|No Intervention: Control group|
- Disease-free/Relapse-free survival [ Time Frame: 5 years ]The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.
- Overall survival [ Time Frame: 5 years ]The time interval from randomization to death from any cause or end of follow-up whichever occurs first.
- Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [ Time Frame: 2 years ]Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
- Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 [ Time Frame: 5 years ]Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.
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): NCT03817268