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

Locally Advanced Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939666
• Other study ID #: MEC 09-2-034
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: March 22, 2017
• Start date: July 1, 2009
• Est. completion date: September 1, 2014

Study information

• Verified date: March 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2014
• Est. primary completion date: September 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Laurentius Hospital Roermond	Roermond

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 Onc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence		2 and 5 years
Secondary	Overall survival		2 and 5 years
Secondary	Disease-free survival		2 and 5 years
Secondary	Distant metastasis-free survival		2 and 5 years
Secondary	Quality of life		6 weeks to 1 year
Secondary	Compliance		2 and 5 years
Secondary	Percentage of patients that chooses the minimal invasive strategies over standard surgery		2-5 years