Comparison 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…
ID
Bron
Verkorte titel
Aandoening
Metastatic colorectal cancer
Male or female > 65 years of age
frail patients
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Comparison of progression free survival
Achtergrond van het onderzoek
Colorectal 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.
Doel van het onderzoek
Comparison 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.
Onderzoeksopzet
Response evaluation every 9 weeks
Onderzoeksproduct en/of interventie
Arm 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
Algemeen / deelnemers
Department of Clinical Oncology
postzone K-1P
J.R. Kroep
Leiden University medical Center
PO box 9600
Leiden 2300 RC
The Netherlands
j.r.kroep@lumc.nl
+31(0)71 5266760
Wetenschappers
Department of Clinical Oncology
postzone K-1P
J.R. Kroep
Leiden University medical Center
PO box 9600
Leiden 2300 RC
The Netherlands
j.r.kroep@lumc.nl
+31(0)71 5266760
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1223 |
| NTR-old | NTR1268 |
| Ander register | 2007-004330-17 : p07.153 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |