Early rectal cancer
Conditions
Interventions
Trade Name: Capecitabine
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria • Biopsy proven adenocarcinoma of the rectum • Magnetic Resonance Imaging (MRI)- or Endorectal Ultrasound (ERUS)-staged TX/T1-3b, NX/N0, MX/M0 rectal tumour • MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) Transanal Endoscopic Microsurgery (TEM) • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 • Willing and able to consent 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Main exclusion criteria • Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years • MRI node positive (=N1, defined by protocol guidelines) • MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines) • MRI defined mucinous tumour • Mesorectal fascia threatened by tumour (= 1mm on MRI or ERUS) • Maximum tumour diameter >40mm (either measured from everted edges on sagittal MRI or ERUS examination) • Anterior tumour location above the peritoneal reflection on MRI or ERUS • No residual luminal tumour following endoscopic mucosal resection • Prior pelvic radiotherapy • Definite evidence of regional or distant metastases (M1) in opinion of MDT • Uncontrolled cardiorespiratory comorbidity (inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry) • Known Dihydropyrimidine Dehydrogenase deficiency • Known Gilbert’s disease • Taking coumarin-derivative oral anticoagulants that cannot be stopped or substituted by low molecular weight heparin • Taking metronidazole, phenytoin, sorivudine or its analogues, such as brivudine • Women who are pregnant or lactating Age <16 years (UK), <18 years (other countries)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The phase III component will evaluate two contrasting organ preservation strategies (either long-course chemoradiotherapy or short-course radiotherapy) for the treatment of early stage rectal cancer in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL). The phase III study will also include a standard TME radical surgery (non- randomised) comparator arm encompassing reconstructive (low anterior resection) and non-reconstructive (abdominoperineal excision, low Hartmann’s procedure) approaches.;Secondary Objective: N/A;Primary end point(s): Primary outcome: The proportion of patients with successful organ preservation at 30 months from the start date of (chemo)radiotherapy. Organ preservation is considered to have failed (a) if the rectum is removed; (b) if the patient develops unequivocal locoregional cancer recurrence or (c) if the patient has a stoma.;Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes: A) Secondary outcomes for the randomised comparison between organ-preserving strategies: • Clinician-reported acute treatment-related toxicity up to 30 days following completion of (chemo)radiotherapy • Proportion of patients with complete response to (chemo)radiation therapy • Proportion of patients undergoing transanal local excision • Time to event of organ loss assessed for patients who prefer organ preservation; defined as the length of time from the start date of trial treatment until TME surgery • Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or development of unequivocal pelvic recurrence but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery • Metastasis-free survival to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or detection of distant metastasis • Non-regrowth -disease free survival to 36 months; defined as the length of time from the start of trial treatment until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery • Overall survival to 60 months; defined as the length of time from the start date of trial treatment until death (any cause) B) Secondary endpoints for analyses incorporating the non-randomised standard surgery comparator: • Clinician-reported acute treatment related toxicity up to 30 days following completion of (chemo)radiotherapy or date of initial surgery • Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause) or development of unequivocal pelvic recurrence but not including patients who preferred organ pre | — |
Countries
Netherlands
Contacts
Public ContactSeyed Qaderi
Radboudumc
Outcome results
None listed