PACT (Patient Preferences in Adjuvant Colorectal Cancer Therapy) - A randomised crossover clinical trial comparing Bolus Fluorouracil/Leucovorin to Capecitabine as treatment for moderate to high risk resected colorectal cancer - PACT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

•Patients over the age of 18
•Written informed consent obtained.
•Clinical indication for colorectal adjuvant chemotherapy i.e.:
o Dukes’ stage C or B colonic or rectal carcinoma, primary fully macroscopically resected (R0 or R1 resection), with no radiological or clinical evidence of metastatic disease (for Dukes’ B patients there must be a clinical indication for adjuvant chemotherapy, based on histological risk factors and patient factors).
o or full resection of recurrent/metastatic colorectal cancer, if the patient was not previously treated with adjuvant chemotherapy.
•Ready to start adjuvant therapy within 12 weeks of cancer resection
•WHO performance status (PS) 0, 1 or 2, and considered by responsible consultant to be fit to undergo either of the possible treatment schedules.
•Baseline laboratory tests (within 1 week prior to randomisation):
o WBC > 3 x109/l and platelet count >100 x109/l
o serum bilirubin = 1.25 x upper limit of normal (ULN), and serum transaminase (either AST or ALT) = 2.5 x ULN
o either estimated creatinine clearance (Cockroft; page 29) >50ml/min or measured GFR (EDTA clearance) >50 ml/min.
•For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•patients planned to receive postoperative radiotherapy or chemoradiotherapy (NB preoperative short-course radiotherapy is not a contraindication)
•severe uncontrolled concurrent medical illness (e.g. poorly-controlled angina, CCF; MI within preceding 3 months).
•Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
•Patients with another cancer within the preceding 3 years
•Pregnant or Lactating females
•Patients requiring ongoing treatment with a contraindicated concomitant medication

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endpoint is patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens;Secondary Objective: •Patient preference at 12 weeks, after experiencing both regimens, according to treatment sequence<br>•Toxicity – maximum NCIC grade toxicity experienced within first cycle of regimen<br>•Quality of Life (QoL) - assessed at baseline, 6, 12 and 24 weeks post-randomisation. Assessed using EORTC QLQ-C30<br>•Dose intensity (DI) – delivered DI as a percentage of planned DI<br>•Safety – comparison of rates of SAEs and SUSARS between the two regimens<br>;Primary end point(s): The primary endpoint is patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens

Secondary Outcome Measures

Name	Time	Method

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