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

ISRCTN	ISRCTN35708246
DOI	https://doi.org/10.1186/ISRCTN35708246
Protocol serial number	MO05/6844
Sponsor	University of Leeds (UK)
Funder	Roche Products Ltd (UK) (Unconditional pharmaceutical study grant)

Submission date: 09/03/2005
Registration date: 19/04/2005
Last edited: 26/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-different-ways-having-chemotherapy-after-srugery-for-bowel-cancer-pact

Contact information

Prof Matthew Seymour
Scientific

Academic Unit of Oncology & Haematology
Dainton Building
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised active controlled crossover group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	PACT
Study objectives	Adjuvant drug therapy reduces the risk of recurrence and death after resection of colorectal cancer, and is recommended routinely for all fit patients if at moderate-to-high risk of recurrence. Standard therapy is intravenous 5-fluorouracil and leucovorin (FU/LV). Large randomised controlled trials have already established that: a. 6 months' FU/LV is as effective as longer courses, and b. Once-weekly treatment is as effective as, but less toxic than, 5 consecutive days repeated monthly. A recent trial (X-ACT) showed with high statistical confidence that oral capecitabine is as effective as intravenous FU/LV, so it presents an attractive alternative option. Capecitabine gave an acceptable toxicity profile in comparison with the FU/LV regimen used in that trial, although that was the 5-days monthly regimen which is known to be more toxic than weekly treatment. Capecitabine is likely to become available for adjuvant use during 2005. Its equivalence of efficacy is not in doubt, but in order to advise patients we will require direct comparative data for the toxicity and acceptability to patients of capecitabine in comparison with the current commonly-used UK standard of weekly bolus FU/LV. The PACT trial will provide that comparison.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	A randomised crossover clinical trial comparing bolus fluorouracil/leucovorin to capecitabine
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-fluorouracil/leucovorin, capecitabine
Primary outcome measure(s)	Patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens
Key secondary outcome measure(s)	1. Patient preference at 12 weeks, after experiencing both regimens, according to treatment sequence 2. Toxicity - maximum NCIC grade toxicity experienced within first cycle of regimen 3. Quality of Life (QoL) - assessed at baseline, 6, 12 and 24 weeks post-randomisation. Assessed using EORTC QLQ-C30. 4. Dose intensity (DI) - delivered DI as a percentage of planned DI 5. Safety - comparison of rates of SAEs and SUSARS between the two regimens
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	74
Key inclusion criteria	Patients aged 18 years or above with 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) OR full resection of recurrent/metastatic colorectal cancer, if the patient was not previously treated with adjuvant chemotherapy.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2005
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Unit of Oncology & Haematology

Leeds
LS16 6QB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/07/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)