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Bi-daily tegafur-uracil (UFT) plus leucovorin (LV) versus capecitabine as first-line therapy in elderly patients with advanced colorectal cancer, unfit or unwilling to receive combination chemotherapy. - A randomized, open-label phase III study -


- candidate number3174
- NTR NumberNTR1268
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-apr-2008
- Secondary IDsp07.153 2007-004330-17
- Public TitleBi-daily tegafur-uracil (UFT) plus leucovorin (LV) versus capecitabine as first-line therapy in elderly patients with advanced colorectal cancer, unfit or unwilling to receive combination chemotherapy. - A randomized, open-label phase III study -
- Scientific TitleBi-daily tegafur-uracil (UFT) plus leucovorin (LV) versus capecitabine as first-line therapy in elderly patients with advanced colorectal cancer, unfit or unwilling to receive combination chemotherapy. - A randomized, open-label phase III study -
- ACRONYMTLC
- hypothesisComparison of progression free survival (PFS) in elderly patients with advanced CRC treated first line by tegafur-uracil plus LV or capecitabine. It is considered that, in this patient population, only differences in the median time to progression of at least 6 weeks or more are medically relevant.
Furthermore, differences in quality adjusted survival, the outcome of geriatric questionnaires and translational questions are studied for both agents.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Elderly patients, Tegafur-uracil (UFT), Leucovorin
- Inclusion criteria1. Signed written informed consent
2. Male or female > 65 years of age
3. Histologically proven advanced CRC; not amenable for curative surgery
4. Life expectancy of > 3 months
5. Unwilling or unfit (in the opinion of the investigator) for combination therapy
6. WHO performance status 0 - 2
7. Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l
8. Bilirubin level < 1.5 x ULN
9. ASAT and ALAT < 2.5 x ULN (< 5 x ULN if liver metastasis are present)
10. Adequate renal function as defined by: serum creatinine clearance > 60 cc/min
11. Expected adequacy of follow-up.
- Exclusion criteria1. Prior chemotherapy for advanced CRC; prior adjuvant chemotherapy is allowed provided that the last administration was given > 6 months prior to randomization.
2. Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
3. In case of previous radiotherapy at least one measurable lesion located outside the irradiated field.
4. Any investigational agent(s) within 4 weeks prior to entry
5. Treatment with brivudine within 1 month
6. Central nervous system metastasis (known or suspected)
7. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
8. Known hypersensitivity reaction to any of the components of the treatment
9. Known drug abuse/ alcohol abuse
10. Partial or complete bowel obstruction
11. Chronic diarrhoea or inflammatory bowel disease
12. Known DPD deficiency
13. Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
14. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent     
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-jan-2008
- planned closingdate1-mei-2010
- Target number of participants300
- InterventionsArm A:
UFT 300 mg/m2 orally, divided in two daily doses, days 1-28
Leucovorin: 60 mg/day orally, divided in two daily doses, days 1-28,
Q5 weeks, until disease progression or unacceptable toxicity
Arm B:
Capecitabine 2500 mg/m2 orally,divided in two daily doses, days 1-14
Q3 weeks, until disease progression or unacceptable toxicity
- Primary outcomeComparison of progression free survival
- Secondary outcome-Quality adjusted survival
-Overall survival
-Delivered dose intensity
-Safety
-Geriatric questionnaires
-Translational research
- TimepointsResponse evaluation every 9 weeks
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. J.R. Kroep
- CONTACT for SCIENTIFIC QUERIESDr. H. Gelderblom
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsAuthors of at least one of the manuscript will include the steering committee, study coordinators, advisors, statistician and the investigators who have included more than 10% of the eligible patients in the trial (by order of inclusion).
- Brief summaryColorectal cancer is often diagnosed in elderly patients with advanced CRC1, who often have more co-morbidity and for whom combination chemotherapy may be associated with greater toxicity and less overall benefit. Currently, the optimal first line chemotherapy for treatment of advanced CRC patients unsuitable to receive combination chemotherapy is not known. The efficacy, favourable tolerability, and ease of administration of both UFT and capecitabine make these treatments ideal for use in patients with advanced CRC considered ineligible for combination chemotherapy. Both drugs have already shown good tolerability and efficacy in the elderly, but have never been compared in a randomised study. Therefore we initiated this randomized phase III study comparing UFT and capecitabine in patients with advanced CRC not suitable for or not willing to receive combination chemotherapy. In order to better monitor the study population we take into account the quality of life analysis, comprehensive geriatric assessments and translational research.
- Main changes (audit trail)
- RECORD8-apr-2008 - 6-nov-2013


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