Clinical trial NCT00939666: 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
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Rectal Cancer
Keywords: Rectal cancer
Chemoradiation
Response
Wait-and-see policy
Transanal endoscopic microsurgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Local recurrence
timeFrame: 2 and 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 and 5 years
measure: Disease-free survival
timeFrame: 2 and 5 years
measure: Distant metastasis-free survival
timeFrame: 2 and 5 years
measure: Quality of life
timeFrame: 6 weeks to 1 year
measure: Compliance
timeFrame: 2 and 5 years
measure: Percentage of patients that chooses the minimal invasive strategies over standard surgery
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Roermond
country: Netherlands
facility: Laurentius Hospital Roermond
Study officials:
affiliation: Maastricht University Medical Center, Maastricht, The Netherlands
name: Geerard L Beets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.