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 capecitabine capecitabine administration and dosage
Conditions
Interventions
Intervention is procedure for initial dosing for capecitabine: dose-escalation protocol (procedure for dosing for capecitabine)
Use same agents as control arm including capecitabine and other chemothe
Experimental Drug,Active Comparator Drug
dose-escalation arm,standard dose arm
Sponsors
principal investigator
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| dose of capecitabine at 4th cycle (Per-Protocol analysis) 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 groups,dose of capecitabine at each cycle every cycle of treatment (at initial of 1st-3rd cycle) Record the dose, prescribed by physician (divided dose by patient's body surface area),Quality of Life every cycle of treatment (at initial of 1st-4th cycle) use the EuroQoL Group's 5-dimension 5-level (EQ-5D-5L), recorded by patients or helped by cousins ,dose interruption every cycle of treatment (at initial of 1st-4th cycle) recorded by investigators, recording: presence/absense, onset of event, reason,dose reduction every cycle of treatment (at initial of 1st-4th cycle) recorded by investigators, recording: presence/absense, onset of event, reason,discontinuation every cycle of treatment (at initial of 1st-4th cycle) recorded by investigators, recording: presence/absense, onset of event, reason,Adverse events every cycle of treatment (at initial of 1st-4th cycle) recorded by investigator (absence/presence, onset, grading per CTCAE version 5.0, and is treatment-related? (Yes/No) for each event) | — |
Countries
Thailand
Contacts
Public ContactThanit Imemkamon
Khon Kaen University
Outcome results
None listed