Informed consent1
|
X
| | | | |
EORTC QLQ-C30
|
X
| | | |
X
|
Curcumin questionnaire
|
X
| | | |
X
|
Medical history
|
X
| | | | |
Physical examination
|
X
| | | | |
Weight, temperature, blood pressure, pulse
|
X
| |
X
|
X
|
X
|
ECOG performance status (Appendix 2)
|
X
| | | |
X
|
12-lead electrocardiogram
|
X
| | | | |
Haematology, liver function, renal function2
|
X
|
Performed as routine prior to each cycle of FOLFOX
|
Urine sample (pregnancy test for female patients)
|
X
| | | | |
Tumour assessment3
|
X
|
3-monthly CT scan to 24 months.
|
6-monthly CT 24 to 48 months when appropriate
|
Serum CEA2
|
X
|
3-monthly CEA until CT scans end
|
Symptom diary
|
X
|
Daily for first 4 weeks
| |
Neurotoxicity questionnaire
|
X
|
Questionnaire every 2 cycles, after cycle 12 or withdrawal
|
Blood samples for curcumin, platinum and biomarker analysis
|
X
|
X
|
X
|
X
|
X4
|
FOLFOX treatment5
| |
Up to 12 cycles, at 2 week intervals
|
Survival
| |
Continuously monitored once protocol therapy has ended6
|