Chemotherapy then Radiation then Immediate Curative Surgery for operable rectal cancer

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Rectal adenocarcinoma

• Registration Number: EUCTR2010-023083-40-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-21
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

All of the following criteria must apply for patients to be included in the trial: 1.Patient 18 years old or older 2.Tumour biopsy with histopathologic confirmation of rectal adenocarcinoma 3.Inferior aspect of tumour is > 4 cm from anal verge on digital examination and pelvic MRI scan 4.Superior aspect of tumour is not higher than the anterior aspect of the S1/S2 interspace on pelvic sagittal MRI scan 5.Further MRI defined inclusion criteria include: (i) Mesorectal fascia is not threatened or involved (tumour > 1mm from mesorectal fascia) (ii) Primary tumour is: • T3a-b (mesorectal primary tumour invasion seen = 5 mm beyond muscularis propria) in the presence of either: extra-mural vascular invasion or mesorectal tumour deposit(s) with irregular border and mixed signal intensity •any T3c (primary tumour invasion seen >5mm beyond muscularis propria)-T4a (invasion of visceral peritoneum for tumours with a component above peritoneal reflection) • Low tumours should not involve levator ani (>1 mm gap between tumour and levator ani) or anal sphincters 6.No evidence of distant metastases 7.Patient with measurable disease at the baseline visit 8.A defunctioning colostomy or ileostomy is permitted to relieve impending rectal obstruction or severe local bowel symptoms 9.Candidate for systemic therapy with OxMdG according to the opinion of the primary oncologist treating the patient 10.ECOG Status: 0-1 11.Bloods: Adequate bone marrow, hepatic, renal and metabolic function (assessed within 14 days prior to study entry): • Haemoglobin = 9 g/dL, leucocyte count = 3 x 109/L, neutrophil count =1.5 x109/L and platelet count =100 x109/L • Total bilirubin = 1.5 x ULRR, alkaline phosphatase = 5 x ULRR, and serum transaminase (either AST or ALT) =2.5 x ULRR • Estimated creatinine clearance = 50 mL/min (calculated according to Cockroft and Gault). (Confirmed with 24 hour urine creatinine clearance or EDTA if estimated creatinine clearance < 50 ml/min) • Magnesium and calcium =LLRR 12.No known significant impairment of intestinal absorption (e.g. chronic diarrhoea, inflammatory bowel disease) 13.Baseline ECG showing no evidence of established or acute ischaemic heart disease (e.g. left bundle branch block, pathological q waves, ST elevation or ST-segment depression) and normal clinical cardiovascular assessment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

If any of the following criteria apply, patients cannot be included in the trial: 1.Disease threatening mesorectal fascia (disease = 1 mm from mesorectal fascia whether this is primary tumour, extra-mural vascular invasion or tumour deposit with irregular border and mixed signal intensity) 2.Stage T4b cancer with invasion into adjacent organs or structures 3.Enlarged pelvic sidewall lymph nodes 4.Distant metastases 5.Severe local bowel symptoms of tenesmus, frequency (at least baseline grade 3 diarrhoea) or incontinence that have not been relieved by a defunctioning colostomy/ileostomy 6.Pelvic sepsis 7.Metallic colonic/ rectal stent in situ 8.Patient who has received previous pelvic radiotherapy 9.Patient with an uncontrolled infection 10.Pregnant, breast feeding or trying to conceive 11.Previous treatment with another investigational antitumoral therapy in the 30 days prior to beginning treatment (including chemotherapy, irradiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibodies, or other experimental drugs) 12.Patients with another previous or current malignant disease which in the judgement of the treating investigator is likely to interfere with treatment or assessment of response 13.Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment/randomization 14.History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan 15.Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment 16.Previous malignancies in the preceding five years except for: •In situ cancer of the uterine cervix •Adequately treated basal cell skin carcinoma •Any early stage malignancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified