E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rectal cancer stage II and III |
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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 |
Primary end point: to set and to compare the portion of complete histopathological remissions between two arms A and B defined by histopathological examination of the surgical sample.
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E.2.2 | Secondary objectives of the trial |
Secondary end points: to set and to compare between arms A and B: downstaging frequency reached by neoadjuvant treatment Portion of anal sphincter sparing surgeries Frequency of local recurrences during 2 and 5 year follow up Disease-free interval Overall survival Frequency and seriousness of adverse events Quality of life |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Newly diagnosed, histologically verified rectal adenocarcinoma, clinical stage II or III (cT3 - 4 N0 M0, or any of cT N1 - 2 M0), localized up to 16cm from anus. Karnofsky index > 70. Age 18-70yrs Complete Blood Count (+differential count): WBC, trombocytes, neutrophils in peripheral blood with no clinical pathology, haemoglobin level at least 100mg/l Hepatic enzymes serum level (ALT,AST,LD,GMT and bilirubin) up to twice as the upper limit of the normal range Serum creatine level less than 140 mmol.l-1, creatine clearance > 60 ml/min. In case of border level of creatinine clearance (45 – 60 ml/min) test may be repeated or specified by kidney scintigraphy (DTPA) and inclusion may be consulted with clinical coordinator. Signed informed consent |
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E.4 | Principal exclusion criteria |
Serious complications demanding acute or subacute treatment (ileus, GIT perforation or clinically important bleeding) Suspicion on synchronic duplicit malignant tumors in the region of rectum or colon, multiple polyposis in the region of rectum or colon Active infectious disease Other malignant tumor disease in the past 5 years excluding basalioma and cervical cancer (carcinoma in situ). Previous radiotherapy of a small pelvis or other treatment of abdomen or small pelvis having large effect on normal anatomy Serious cardiovascular disease Serious mental disease, active or present in patient history Fluoropyrimidine related serious unexpected reaction Capecitabine(Xeloda®), 5-fluorouracil or any of present substances hypersensitivity Autoimmune disease, active or in patient history Known DPD (dihydropryimidine dehydrogenasis) deficiency Enormous vomiting or any other state excluding oral administration Sirovudine concomitant administration of of its chemical analog Peroral anticoagulans administration (warfarin) Gravidity or breastfeeding Presence of any mental, familiar, social or geographic facts that may be collide with protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point: to set and to compare the portion of complete histopathological remissions between two arms A and B defined by histopathological examination of the surgical sample. |
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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 | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | Yes |
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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The trial is planned for 7 years, patients recruitment is set for 24 months with 60 months follow-up. All is provided in the protocol.
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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 | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |