Patients With Rectal Cancer: a "Wait-and-see" Approach

Official Title

Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach

Summary:

Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiation therapy to a dose of 45Gy in 25 fractions with a tumour boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumour), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.

Trial Description

Primary Outcome:

• Feasibility of a "wait and see" approach

The combination of preoperative (chemo)radiotherapy and total mesorectal excision (TME) has been shown to reduce the risk of local recurrence in patients with resectable adenocarcinoma of the rectum. The improved local control rates come at the price of an increased risk of surgical complications, including a postoperative death rate of 2-8 percent which may reach 30 per cent at 6 months in those aged over 85 years, as well as long-term impact on anorectal, urinary and sexual function. Patients with cancers in the low rectum in close proximity to the sphincter muscles, may require a permanent stoma, which can be associated with high psychological morbidity. Preoperative chemoradiotherapy followed by a delay to resection can produce pathological complete responses. One review of phase II and III studies identified an overall pCR rate of 13.5%, but even higher rates of pCR have been observed with doses of radiation therapy exceeding 45 Gy . Certainly patients who proceed to radical surgery after achieving a pCR with chemo radiation do have favourable long-term outcomes. But do patients whose tumour has already been sterilized by chemo radiation therapy need to proceed with radical surgery? A number of studies have now emerged highlighting the rationale of a 'wait and see' policy for patients who achieve a complete clinical response (cCR) after chemo radiation therapy. The majority of the clinical data supporting this approach have come from Brazil. The Brazilian data suggests that observation of such patients yields survival rates similar to those of patients who undergo radical surgery with confirmation of pCR. More recent studies from the United Kingdom and the Netherlands appear to support the feasibility of this approach. To date there is no published prospectively collected data of a wait-and-see policy from a North American Centre.

View this trial on ClinicalTrials.gov