Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer

Summary

The proposed study is an observational, prospective, multicenter study of patients undergoing neoadjuvant therapy for medium-low rectal cancer.

Recently the investigators have published the findings of a multicenter Italian phase II study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy (pCRT), showed a major clinical response and underwent a transanal local excision. Based on these results, an organ-sparing approach for patients showing a major clinical response is feasible without reducing the good results obtained with the standard treatment. While a phase III trial is the best way to compare the standard treatment with the organ-sparing approach (local excision or wait-and-see) it is impracticable and likely unethical. An observational study is therefore one of the best way to evaluate the impact that an organ-sparing approach may have on oncological outcomes, quality of life, and bowel function for patients with rectal cancer who, after a pCRT, show a clinical major/complete response.

This phase II trial is designed to test the hypothesis that conservative treatments, in patients with low-mid rectal cancer who undergo a major or complete clinical response after neoadjuvant treatment, will be safe and effective compared to standard surgery.

The investigators will compare rectum-sparing approaches to standard surgery, firstly in terms of rate of organ preservation at 2 years. Additionally they will compare survival outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete response, correlation between major and complete clinical response.

To add value, the investigators will measure QoL in patients treated with rectum-sparing approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal amputation).

Rectum-sparing approach can be considered clinically acceptable if percentage of conservation of the rectum at two years is not less than 50%.

The collected data on 164 patients who underwent "rectum-sparing" allow to test the hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it obtains a frequency of conservation of the rectum of not less than 87 cases.

The analysis results will be reported in accordance with STROBE guidelines (von Elm et al., 2008). For all analyzes, continuous variables are described using the mean and standard deviation of position and appropriate measures when appropriate. Categorical variables will be described using the contingency tables.

Conditions

• Rectal Neoplasms

Interventions

PROCEDURE

Local Excision or Wait-and-See

Local excision can be done both with traditional technique and with endoscopic technique (TEM, TAMIS, etc.). The following principles should be respected: 1. A gross margin of at least 0.5 cm; 2. full-thickness excision including mucosa, submucosa, muscle and peri-rectal fat; 3. determination of the specimen on the support by pins at the edges in order to facilitate the interpretation of histological pathologist.

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS

  collaborator OTHER

• Centro di Riferimento Oncologico - Aviano

  collaborator OTHER

• Istituto Nazionale per lo Studio e la Cura dei Tumori

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Ospedali Riuniti

  collaborator OTHER

• University of Padova

  lead OTHER

Principal Investigators

• Salvatore Pucciarelli, MD · University of Padova

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2021-01-31

Completion

2021-08-31

Countries

• Italy

Study Locations