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

NCT00939666 | Completed DMC

• 1 other identifier: MEC 09-2-034
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

Rectal cancer; Chemoradiation; Response; Wait-and-see policy; Transanal endoscopic microsurgery

Outcome Measures

Primary Outcomes (1)

• Local recurrence

  2 and 5 years

Secondary Outcomes (6)

• Overall survival

  2 and 5 years

• Disease-free survival

  2 and 5 years

• Distant metastasis-free survival

  2 and 5 years

• Quality of life

  6 weeks to 1 year

• Compliance

  2 and 5 years

Study Arms (1)

Wait&see or TEM with intensive follow-up

EXPERIMENTAL

All patients will be included in this arm

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

Interventions

Wait&see or TEM with intensive follow-up PROCEDURE

Wait\&see or TEM with intensive follow-up

Wait&see or TEM with intensive follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Laurentius Hospital Roermond

Roermond, Netherlands

Location

Related Publications (2)

• Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe 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.

  PMID: 22067400 RESULT

• Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2.

  PMID: 33725387 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Geerard L Beets, MD, PhD

  Maastricht University Medical Center, Maastricht, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

NL (2)