E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Poor risk operable rectal adenocarcinoma | |
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 evaluate the improvement in pathological complete response rate from the addition of cetuximab to neoadjuvant oxaliplatin and capecitabine followed by synchronous chemoradiation and total mesorectal excision in patients with magenetic resonance imaging (MRI) defined poor risk rectal cancer | |
E.2.2 | Secondary objectives of the trial | (1)Radiological response rates after neoadjuvant chemotherapy and after completion of all neoadjuvant chemoradiotherapy. (2)Complete resection rate (R0 resection) with microscopic clear resection margin (tumour observed >1mm from the resection margin), especially circumferential resection margin (3)Perioperative measures including operation time, duration of in-patient stay, perioperative transfusion requirement and mortality within 30 days of operation. (4)Post-operative complications including wound infection, wound dehiscence fistula formation (5) Quality of total mesorectal excision (TME) as graded by audit of photographed surgical specimens. (6)Rate of abdominoperitoneal excision (APE) (7)Rate of permanent defunctioning colostomies. (8)Clinical and radiological anastomotic leak rate.(9)Progression free survival and patterns of failure (10)Overall survival (11)Safety (12)Quality of life. | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | b)Histological diagnosis of adeno- or undifferentiated non-small cell carcinoma of rectum. c)Poor risk operable rectal cancer as defined by the presence on MRI of at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved ii) T3 tumours at/below levators iii) Tumours extending 5mm into peri-rectal fat iv) T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins) v) Presence of extra-mural venous invasion (primary tumour is therefore at least T3) d)WHO performance status 0-2. | |
E.4 | Principal exclusion criteria | a)Any contraindications to MRI (eg. patients with pacemaker. c)Patients with rectal cancer which is deemed inoperable at diagnosis should not be entered into the study even if they are potentially operable if their primary is successfully downstaged by neoadjuvant treatment. This includes patients with locally advanced inoperable disease, such as tumour extending beyond the mesorectal fascia into pelvic side wall structures, or situations where surgical resection with clear margins is unlikely to be possible. d)T1-2 rectal cancer at any level. e)Presence of metastatic disease or recurrent rectal tumour. | |
E.5 End points |
E.5.1 | Primary end point(s) | Pathological complete response rate at total mesorectal excision. | |
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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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 | 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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | End of trial= last visit of last subject of study. | |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |