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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00939666
First received: July 14, 2009
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Locally Advanced Rectal Cancer
Procedure: Wait&see or TEM with intensive follow-up

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Local recurrence [ Time Frame: 2 and 5 years ]

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

Enrollment: 28
Study Start Date: July 1, 2009
Study Completion Date: September 1, 2014
Primary Completion Date: September 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939666

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Laurentius Hospital Roermond
Roermond, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Geerard L Beets, MD, PhD Maastricht University Medical Center, Maastricht, The Netherlands
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00939666     History of Changes
Other Study ID Numbers: MEC 09-2-034
Study First Received: July 14, 2009
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Pooling of data is expected in the future

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
Rectal cancer
Chemoradiation
Response
Wait-and-see policy
Transanal endoscopic microsurgery

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 21, 2017