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 |
| Secondary identifying numbers | MO05/6844 |
- 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
Contact information
Prof Matthew Seymour
Scientific
Scientific
Academic Unit of Oncology & Haematology
Dainton Building
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom
Study information
| Study design | Randomised active controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil/leucovorin, capecitabine |
| Primary outcome measure | Patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2005 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Academic Unit of Oncology & Haematology
Leeds
LS16 6QB
United Kingdom
LS16 6QB
United Kingdom
Sponsor information
University of Leeds (UK)
Industry
Industry
Room 7.11, Level 7
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Industry
Roche Products Ltd (UK) (Unconditional pharmaceutical study grant)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 10/07/2008 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
