rectal adenocarcinoma rectal cancer rectal cancer
Conditions
Interventions
Arm 1: Contact x-ray brachytherapy will be given applied after randomisation
with a maximum interval of 14 weeks after finishing the neoadjuvant
(chemo)radiation. Contact x-ray brachytherapy consist
patients in whom an incomplete response or disease
progression is noted, completion or salvage TME-surgery is advised.
Arm 2: The waiting interval will be extended with 6-8 more weeks after the
firs
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • histologically verified adenocarcinoma above the dentate line and within 10cm of the anal verge; • neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed re-sponse evalation according to the Dutch national guidelines (cT1-3, cN1-2 lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without pres-ence of significant distant metastases) without full dose chemotherapy in the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR • neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1) LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal status, lateral lymph node involvement, and/or involved MRF, without the presence of significant distant metastases) or 2) early rectal cancer or IRC and a strong wish for organ preservation; • clinically near-complete response or a small residual tumour mass 18 years; • written informed consent.
Exclusion criteria
Exclusion criteria: • neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation, e.g. patients with a Rapido or M1-scheme are not eligible; • radiation dose >50.4 Gy or boost dose on the primary tumour; • presence of suspicious lymph nodes (yN1/N2) at first response evaluation; • residual tumour >= 3cm or over half of the circumference of the rectal lumen; • patients who are unable to undergo contact x-ray brachytherapy or local excision; • patients who cannot tolerate a completion- or salvage-TME because of comorbidi-ty or frailty;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the OPAXX study reflects the efficacy of both additional treatment options: the rate of successful organ preservation (defined as an in-situ rectum, no defunctioning stoma and absence of active locoregional cancer failure) at one year following randomisation in rectal cancer patients with a good, but not complete clinical response after (chemo)radiation. For patients with a good but not complete clinical response after (chemo)radiation who are not eligible for randomisation in the OPAXX study an observational cohort study is conducted (OPAXX registration study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are related to toxicity and morbidity of the two additional treatment options in the randomisation study, as well as to oncological and functional outcomes at one, two and five years of follow-up, and cost-utility. | — |
Countries
Netherlands
Contacts
Public ContactY.Q.E.R. Tankink
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed