Non-operative Management for Locally Advanced Rectal Cancer

Titre officiel

Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer

Sommaire:

Il s’agit d’une étude de phase II d’une durée de 5 ans visant à évaluer l’innocuité d’une intervention non opératoire (INO) chez des patients atteints d’un cancer du rectum bas ayant obtenu une réponse clinique complète (RCc) suivant une chimioradiothérapie (CRT). L’innocuité de l’INO sera évaluée en fonction de ce qui suit : i) taux de nouvelle croissance locale; et ii) taux de marge de résection macroscopique positive (T2) suivant une intervention chirurgicale obligatoire due à une nouvelle croissance locale. L’INO sera considérée comme sûre ou aussi efficace que l’intervention chirurgicale pour maîtriser localement la maladie si le taux de nouvelle croissance locale est égal ou inférieur à 30 % et si le taux de marge macroscopique positive est de 0 %.

Description de l'essai

Primary Outcome:

  • Rate of local re-growth
  • Rate of macroscopically positive resection margin
Secondary Outcome:
  • Rate of overall survival
  • Rate of disease-free survival
  • Colostomy-free survival
  • Quality of Life
  • Bowel Function
Background: The standard treatment for low rectal cancer (LRC) involving the anal sphincter involves combined, pre-operative chemotherapy and radiation therapy (CRT) followed by surgery. Surgery involves removal of the rectum and anus and creation of a permanent colostomy and has significant long term effects on bowel and sexual function and body image. Because of the high morbidity of surgery, there has been increasing interest in non-operative management (NOM) for LRC. The NOM approach involves deferral of surgery and active surveillance of all patients with LRC who have achieved a complete clinical response (i.e., have no residual tumour) following completion CRT which occurs in approximately 30% of patients. To date, while there have been a few, prospective single institution studies that have shown favourable results with NOM, this approach has not been adopted into clinical practice due to concerns from physicians about the safety of NOM based on the limited evidence available.

Objectives: Therefore, the objective of this study is to conduct a pan-Canadian Phase II trial to assess the safety of NOM for LRC.

Methods: All patients with LRC requiring surgery and a permanent colostomy being treated at the participating centres will be assessed for complete clinical response (cCR) eight to ten weeks following the completion of CRT by the treating surgeon. For the study, a cCR will be defined as (i) no palpable tumour on digital rectal exam, (ii) no residual tumour defined as white-yellow, flat scar on endoscopy, (iii) no residual tumour on MRI, (iv) no suspicious mesorectal or extramesorectal lymph nodes on MRI and (v) normal CEA level. Patients who meet all of these criteria for cCR will be invited to participate in the study. Patients who consent to participate in the study will undergo active surveillance that will include DRE, endoscopy and pelvic MRI every 3, 6, 9, 12, 18 and 24 months; CEA levels every 3, 6, 9, 12, 15, 18, 21, 24 months and CT chest/abdomen and pelvis every 6, 12, 18 and 24 months. The primary outcome for the study will be the rate of local re-growth 2 years following the completion of CRT. Local re-growth will be defined as failure to meet the cCR criteria at any time point. NOM will be considered safe, if the rate of local re-growth is less than 30% two years after the completion of CRT. The secondary outcomes for the study will be the rate of distant recurrence, disease free and overall survival at 2 years.

Significance: The results of this study will be highly clinically relevant since it is expected that NOM for LRC will be safe and will have significant potential to change clinical practice in Canada and North America since approximately 30% of patients with LRC would be able to safely avoid surgery and a permanent colostomy and have improved bowel and sexual function and body image. Furthermore, widespread adoption of NOM has the potential to increase health care capacity and decrease treatment costs by reducing the number of surgeries, hospital admissions and costs associated with both surgery and long term surgical morbidity.

Voir cet essai sur ClinicalTrials.gov

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