Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy

• ClinicalTrials.gov Identifier: NCT02052921
• Recruitment Status: Terminated
• First Posted: February 3, 2014
• Last Update Posted: May 11, 2020
• Sponsor: Instituto do Cancer do Estado de São Paulo
• Information provided by (Responsible Party): Instituto do Cancer do Estado de São Paulo

Tracking Information

• First Submitted Date: January 31, 2014
• First Posted Date: February 3, 2014
• Last Update Posted Date: May 11, 2020
• Actual Study Start Date: November 2011
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2014): Disease-free survival (DFS) [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 31, 2014): Operative complication rate [ Time Frame: 30 days ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 31, 2014)

• Presence of viable tumor in the surgical specimen [ Time Frame: 3 years ]
• Pattern of recurrence [ Time Frame: 3 years ]
• Overall survival (OS) [ Time Frame: 5 years ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy
• Official Title: Open Randomized Study of Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rectal Cancer

Intervention

• Procedure: Rectal resection
  Surgical rectal resection
• Other: Observation

Study Arms

• Active Comparator: Rectal resection
  Surgical rectal resection
  Intervention: Procedure: Rectal resection
• Experimental: Observation
  Conservative approach
  Intervention: Other: Observation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 7, 2020): 13
• Original Estimated Enrollment (submitted: January 31, 2014): 150
• Actual Study Completion Date: April 23, 2020
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histological diagnosis of rectal adenocarcinoma
• tumors located within 10 cm from the anal verge by rigid proctoscopy measurement
• Complete clinical response after neoadjuvant treatment with chemoradiotherapy for rectal tumors clinical and radiologically staged as T3-4 N0 M0 or T (any) N + M0
• Absence of colorectal synchronous tumors
• Age between 18 and 75 years
• ECOG performance scale ≤ 2,
• last dose of chemotherapy / radiation therapy in up to 12 weeks
• Good organic function
• Absence of serious comorbidities defined by the doctor to prevent surgical resection of the rectum and / or neoadjuvant therapy.

Exclusion Criteria:

• Comorbidities clinically significant where surgical resection and / or neoadjuvant therapy is impossible, according to medical assessment.
• Prior antineoplastic therapy different from neoadjuvant therapy.
• History of Crohn's disease or ulcerative colitis.
• Confirmation or strongly suspected inherited polyp syndrome.
• Pregnant women or during lactation (women of childbearing age should have a negative pregnancy test).
• Concurrent participation in another research protocol involving therapeutic intervention.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02052921
• Other Study ID Numbers: NP172/11
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Instituto do Cancer do Estado de São Paulo
• Original Responsible Party: Same as current
• Current Study Sponsor: Instituto do Cancer do Estado de São Paulo
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ivan Cecconello, MD; Faculdade de Medicina da USP
• Study Director: Ulysses Ribeiro, MD; Instituto do Câncer do Estado de São Paulo

• PRS Account: Instituto do Cancer do Estado de São Paulo
• Verification Date: May 2020