Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT01053104
Eligibility Criteria:
Inclusion Criteria:
* Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens
For metastatic colorectal cancer:
* capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
* capecitabine 2500mg/m2 d 1-14, q 3 weekly
For metastatic breast cancer:
* capecitabine 2000mg/m2d 1-14, q 3 weekly
* capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
* Age \> 18 years
* Fit to start at full (100%) starting dose of all drugs
* Able and willing to use mobile phone
* Reasonable renal, liver and bone marrow function
* Absolute neutrophil count (ANC) \>1.5 x 109/L
* Platelet count \> 100 x 109/L
* Total bilirubin \<1.5 ULN
* ALT, AST \< 2.5 x ULN
* Alkaline phosphatase \< 2.5 x ULN
* No obvious contra indications to capecitabine or oxaliplatin or docetaxel
* Patients must also be able to read, write and understand English.
Exclusion Criteria:
* Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials
* Moderate or severe renal impairment \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01053104
Study Brief:
Protocol Section:
NCT01053104