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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2009

Last Updated Date

March 22, 2017

Start Date ^ICMJE

July 1, 2009

Primary Completion Date

September 1, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Local recurrence [ Time Frame: 2 and 5 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00939666 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Condition ^ICMJE

Locally Advanced Rectal Cancer

Intervention ^ICMJE

Procedure: Wait&see or TEM with intensive follow-up

Wait&see or TEM with intensive follow-up

Study Arms

Experimental: Wait&see or TEM with intensive follow-up

All patients will be included in this arm

Intervention: Procedure: Wait&see or TEM with intensive follow-up

Publications *

Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewé KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 1, 2014

Primary Completion Date

September 1, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Netherlands

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00939666

Other Study ID Numbers ^ICMJE

MEC 09-2-034

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:	Undecided
Plan Description:	Pooling of data is expected in the future

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Geerard L Beets, MD, PhD

Maastricht University Medical Center, Maastricht, The Netherlands

PRS Account

Maastricht University Medical Center

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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