Rectal Cancer Clinical Trial
Official title:
Open Randomized Study of Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy
With the possibility of pathological complete response in surgical specimens, some authors
have proposed non-operative management of the patient group, when re-staged after neoadjuvant
treatment, have complete clinical response. So far, this approach remains discussed in the
literature, and there are still many uncertainties that patients with clinical complete
response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of
radical surgical treatment. It is a still investigational approach and actually gained space
even for patients with very high or who refuse surgery after all clarifications surgical
risk.
Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and
distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant
chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who
underwent surgical rectal resection.
This will be a prospective, randomized, open label phase II of surgical resection versus
conservative treatment (observation) in patients with mid and distal rectal cancer who
achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.
The main objective of this study is to assess whether conservative approach is similar to
rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum
in patients with complete clinical response after neoadjuvant therapy combined
chemoradiotherapy.
Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of
rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical
response after treatment with chemoradiotherapy for rectal tumors staged clinical and
radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.
Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The
period for randomization of patients will be 12 weeks after the last dose of radiotherapy /
chemotherapy, so that we can properly assess the antitumor response as described above. After
randomization, patients in the surgical group will undergo resection of the rectum with
complete excision of mesorectal within 2 weeks after randomization.
n/a
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