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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00939666
First received: July 14, 2009
Last updated: July 21, 2011
Last verified: July 2011
  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 Phase
Locally Advanced Rectal Cancer
Procedure: Omission of surgery or transanal endoscopic microsurgery, combined with intensive follow-up
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Local recurrence [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]
  • Distant metastasis-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 6 weeks to 1 year ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
  • Percentage of patients that chooses the minimal invasive strategies over standard surgery [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: July 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minimal invasive strategies Procedure: Omission of surgery or transanal endoscopic microsurgery, combined with intensive follow-up
Omission of surgery or transanal endoscopic microsurgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contacts
Contact: Monique Maas, MD +31433876957 moniquemaas@live.nl
Contact: Geerard L Beets, MD, PhD +31433875492 g.beets@ah.unimaas.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Geerard L Beets, MD, PhD    +31433875492    g.beets@ah.unimaas.nl   
Contact: Monique Maas, MD    +31433876957    moniquemaas@live.nl   
Principal Investigator: Geerard L Beets, MD, PhD         
Sub-Investigator: Monique Maas, MD         
Laurentius Hospital Roermond Not yet recruiting
Roermond, Netherlands
Contact: Jeroen WA Leijtens, MD    +31475382222    j.leijtens@lzr.nl   
Principal Investigator: Jeroen WA Leijtens, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Geerard L Beets, MD, PhD Maastricht University Medical Center, Maastricht, The Netherlands
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geerard L Beets, MD, PhD, 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: July 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 July 22, 2014