Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer

March 22, 2017 updated by: Maastricht University Medical Center

Minimal Invasive Treatment for Patients With Good Response to Chemoradiation With Selection and Follow-up by MRI: a Single Arm Phase-II Feasibility Study in Rectal Cancer

The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME) or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center
      • Roermond, Netherlands
        • Laurentius Hospital Roermond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)
  • Informed consent and capability of giving informed consent
  • Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).

Exclusion Criteria:

  • Recurrent rectal cancer.
  • Distant metastasis.
  • Unable or unwilling to comply to the intensive follow-up schedule.
  • Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wait&see or TEM with intensive follow-up
All patients will be included in this arm
Procedure: Wait&see or TEM with intensive follow-up
Wait&see or TEM with intensive follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local recurrence
Time Frame: 2 and 5 years
2 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 and 5 years
2 and 5 years
Disease-free survival
Time Frame: 2 and 5 years
2 and 5 years
Distant metastasis-free survival
Time Frame: 2 and 5 years
2 and 5 years
Quality of life
Time Frame: 6 weeks to 1 year
6 weeks to 1 year
Compliance
Time Frame: 2 and 5 years
2 and 5 years
Percentage of patients that chooses the minimal invasive strategies over standard surgery
Time Frame: 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Geerard L Beets, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-2-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pooling of data is expected in the future

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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