EUCTR2005-000686-19-GB
Active, not recruiting
Phase 1
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
niversity of Leeds0 sites74 target enrollmentApril 1, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to high risk resected colorectal cancer
- Sponsor
- niversity of Leeds
- Enrollment
- 74
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
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 cancerColorectal cancerCancerMalignant neoplasm of other and ill-defined digestive organsISRCTN35708246niversity of Leeds (UK)74
Completed
Not Applicable
Patient preference for colorectal cancer surveillance strategy in inflammatory bowel disease: a discrete choice experimentNL-OMON29540MC Utrecht400
Completed
Not Applicable
Patient preferences for colonoscopy, CT colonography, and bowel preparation: prospective comparative study in patients with fecal immunochemical test positive.colorectal cancer,colorectal polypJPRN-UMIN000009456Hokkaido Gastroenterology Hospital1,000
Withdrawn
Not Applicable
Apatinib for Resectable Colorectal CancerApatinibOutcome, FatalColorectal CancerSurgeryAdjuvant ChemotherapyNCT03228043Nanchong Central Hospital
Completed
Not Applicable
Understanding Patient Preference on Colorectal Cancer Screening OptionsColorectal CancerNCT05536713Milton S. Hershey Medical Center297