Condition category
Cancer
Date applied
09/03/2005
Date assigned
19/04/2005
Last edited
17/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Matthew Seymour

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MO05/6844

Study information

Scientific title

Acronym

PACT

Study hypothesis

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

Not provided at time of registration

Study design

Randomised active controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

A randomised crossover clinical trial comparing bolus fluorouracil/leucovorin to capecitabine

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil/leucovorin, capecitabine

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

74

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2005

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Oncology & Haematology
Leeds
LS16 6QB
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Room 7.11
Level 7
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Roche Products Ltd (UK) (Unconditional pharmaceutical study grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18612156

Publication citations

  1. Results

    Hennig IM, Naik JD, Brown S, Szubert A, Anthoney DA, Jackson DP, Melcher AM, Crawford SM, Bradley C, Brown JM, Seymour MT, Severe sequence-specific toxicity when capecitabine is given after Fluorouracil and leucovorin., J. Clin. Oncol., 2008, 26, 20, 3411-3417, doi: 10.1200/JCO.2007.15.9426.

Additional files

Editorial Notes