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

Tracking Information
First Submitted Date ICMJE	July 14, 2009
First Posted Date ICMJE	July 15, 2009
Last Update Posted Date	March 24, 2017
Study Start Date ICMJE	July 1, 2009
Actual Primary Completion Date	September 1, 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 14, 2009)	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; (submitted: March 22, 2017)	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; (submitted: July 14, 2009)	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 Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); 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
Actual Enrollment ICMJE; (submitted: July 14, 2009)	28
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 1, 2014
Actual 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	No
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