High risk operable rectal adenocarcinoma MedDRA version: 13.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: erbitux
Product Name: Erbitux
Product Code: N/A
Pharmaceutical Form:
INN or Proposed INN: Cetuximab
Concentr
Sponsors
Royal Marsden NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: b) Histological diagnosis of adeno- or undifferentiated non-small cell carcinoma of rectum. c) High 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 or more into peri-rectal fat iv) T4 tumours v) Presence of extra-mural venous invasion (primary tumour is therefore at least T3) d) WHO performance status 0-2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. in the absence of other high risk factors (e.g. patients with T2 tumours withing 1 mm of mesorectal fascia may be entered in the study). e) Presence of metastatic disease or recurrent rectal tumour.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the improvement in complete response rate from the addition of cetuximab to neoadjuvant oxaliplatin and capecitabine followed by synchronous chemoradiation and total mesorectal excision in patients with magnetic resonance imaging (MRI) defined high risk rectal cancer and Kras/B-raf wild type;Secondary Objective: (1)Complete response after neoadjuvant chemoradiotherapy and/or surgery in all patients(2)Radiological response rates after neoadjuvant chemotherapy . (3)R0 resection rate (tumour observed >1mm from the resection margin), especially circumferential resection margin(4)Perioperative measures including operation time, duration of in-patient stay, perioperative transfusion requirement and mortality within 30 days of operation.(5)Post-op complications (6)Quality of TME (7)Rate of abdominoperitoneal excision (APE)(8)Rate of permanent defunctioning colostomies.(9)Clinical and radiological anastomotic leak rate.(10)PFS and patterns of failure(11)OS(12)Safety(13)QoL including long term bowel function(14)Evaluation of molecular and genetic predictors of response to anti-EGFR treatment. (15)Evaluation of gene expression changes which occur in response to treatment with cetuximab, and to correlate these changes with response to treatment and prognosis.;Primary end point(s): Complete response after neoadjuvant chemoradiotherapy and/or surgery in patients with Kras/Braf wild type tumours. | — |
Countries
Spain, Sweden, United Kingdom
Outcome results
None listed