E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced rectal cancer |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the pathological complete response (pCR) rate in patients treated with capecitabine plus standard radiotherapy of the pelvic region followed by surgery |
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E.2.2 | Secondary objectives of the trial |
To assess the clinical tumor and lymph node response rate to chemo-radiotherapy. To evaluate the safety profile of capecitabine in combination with pelvic radiotherapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with histologically or cytologically confirmed diagnosis of rectal carcinoma, who are planned to have surgery for rectal cancer and are considered to have benefit from pre-operative combined chemo-radiotherapy, (stage cT3, cT4, fixative tumors, tumors primarily inoperaberable - Age more than 18 and less than 80 years – Outpatients, with ECOG performance status 0-2 – Patients willing and able to comply with the study protocol – Written informed consent
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E.4 | Principal exclusion criteria |
– Prior radiotherapy or chemotherapy for colorectal cancer. – Serious comorbidities: Congestive heart failure, angina pectoris, previous history of myocardial infarction, uncontrolled hypertension or arrhythmias. History of significant neurological or psychiatric disorders including dementia or seizures. Serious uncontrolled active infection. Other serious comorbidities that could affect patients safety during study – Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening. – Pregnant or lactating women. – Women of child-bearing potential unless using a reliable and appropriate contraceptive method (post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). – Sexually active males unwilling to practice contraception during the study. – Life expectancy of < 3 months. – Neutrophils < 2 x 109/L or platelets < 100 x 109/L. – Total bilirubin > 1.5 x the upper-normal limits (UNL) of the Institutional normal values and ASAT,ALAT, GMT > 2.5 x UNL, alkaline phosphatase > 2.5 x UNL – Creatinine > 150 micromol/L or creatinine clearance < 30ml/min. – Significant stomach or small intestine disease. – Hypersensitivity to capecitabine, some of the excipients or flurouracil. – Known deficit of dihydropyrimidindehydrogenase (DPD). – Treatment with sorivudine or with chemically related analogues, e.g. brivudine
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E.5 End points |
E.5.1 | Primary end point(s) |
Pathological confirmed complete response (pCR) rate, in patients treated with capecitabine plus ´standard technique´ radiotherapy of pelvic region. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |