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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939666
First Posted: July 15, 2009
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
July 14, 2009
July 15, 2009
March 24, 2017
July 1, 2009
September 1, 2014   (Final data collection date for primary outcome measure)
Local recurrence [ Time Frame: 2 and 5 years ]
Same as current
Complete list of historical versions of study NCT00939666 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Locally Advanced Rectal Cancer
Procedure: Wait&see or TEM with intensive follow-up
Wait&see or TEM with intensive follow-up
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
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.
 
Completed
28
September 1, 2014
September 1, 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00939666
MEC 09-2-034
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Plan Description: Pooling of data is expected in the future
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Geerard L Beets, MD, PhD Maastricht University Medical Center, Maastricht, The Netherlands
Maastricht University Medical Center
March 2017

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