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

Primary Purpose

Locally Advanced Rectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Wait&see or TEM with intensive follow-up

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring Rectal cancer, Chemoradiation, Response, Wait-and-see policy, Transanal endoscopic microsurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Maastricht University Medical Center
Laurentius Hospital Roermond

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wait&see or TEM with intensive follow-up

Arm Description

All patients will be included in this arm

Outcomes

Primary Outcome Measures

Local recurrence

Secondary Outcome Measures

Overall survival

Disease-free survival

Distant metastasis-free survival

Quality of life

Compliance

Percentage of patients that chooses the minimal invasive strategies over standard surgery

Full Information

NCT ID

NCT00939666

First Posted

July 14, 2009

Last Updated

March 22, 2017

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00939666

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2009 (undefined)

Primary Completion Date

September 1, 2014 (Actual)

Study Completion Date

September 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wait&see or TEM with intensive follow-up

Arm Type

Experimental

Arm Description

All patients will be included in this arm

Intervention Type

Procedure

Intervention Name(s)

Wait&see or TEM with intensive follow-up

Intervention Description

Wait&see or TEM with intensive follow-up

Primary Outcome Measure Information:

Title

Local recurrence

Time Frame

2 and 5 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

2 and 5 years

Title

Disease-free survival

Time Frame

2 and 5 years

Title

Distant metastasis-free survival

Time Frame

2 and 5 years

Title

Quality of life

Time Frame

6 weeks to 1 year

Title

Compliance

Time Frame

2 and 5 years

Title

Percentage of patients that chooses the minimal invasive strategies over standard surgery

Time Frame

2-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geerard L Beets, MD, PhD

Organizational Affiliation

Maastricht University Medical Center, Maastricht, The Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

Country

Netherlands

Facility Name

Laurentius Hospital Roermond

City

Roermond

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Pooling of data is expected in the future

Citations:

PubMed Identifier

22067400

Citation

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.

Results Reference

result

PubMed Identifier

33725387

Citation

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.

Results Reference

derived

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

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