Effect of dose-escalation protocol for capecitabine on dose in 4th cycle of chemotherapy
- Conditions
- Patients whose age is above 18 years old who suffered from metastatic breast cancer, colorectal cancer, gastroesophageal adenocarcinoma, or gastric cancer indicated for capecitabine combination regimen and justified to use capecitabinecapecitabineadministration and dosage
- Registration Number
- TCTR20230407003
- Lead Sponsor
- principal investigator
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated (Halted Prematurely)
- Sex
- All
- Target Recruitment
- 18
Patients suffered from metastatic breast cancer, colorectal cancer, gastroesophageal adenocarcinoma, or gastric cancer indicated for capecitabine combination regimen and justified to use capecitabine attended to Medical Oncology outpatient department Srinagarind hospital from 20th July 2022 to 31st October 2022. Due to slow accrual, the inclusion period was amended to add period from 17th November 2022 to 31st December 2022. The Eastern Cooperative Oncology Group performance status must be 0 or 1 and adequate organ function was required. Women of childbearing age and potential must have negative pregnancy test result and have adequate contraception.
Patients with incomplete recovery from surgery (if done), patient with resectable metastasis colorectal cancer, history of other malignancies within 5 years, any concomitant use of other investigational agents during the study treatment period, history of capecitabine allergy, pregnancy, breast-feeding, concomitant use of vitamin K antagonist or uncontrolled medical conditions judged by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method dose of capecitabine at 4th cycle at initial of 4th cycle of treatment Record the dose prescribed by physician (divided dose by patient's body surface area; record for 4 digits without decimal) for assessment of noninferiority of mean difference between two group
- Secondary Outcome Measures
Name Time Method