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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Rectal Cancer

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local recurrence

Outcome Time Frame:

2 and 5 years

Safety Issue:

Yes

Principal Investigator

Geerard L Beets, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Center, Maastricht, The Netherlands

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC 09-2-034

NCT ID:

NCT00939666

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Locally Advanced Rectal Cancer
  • Rectal cancer
  • Chemoradiation
  • Response
  • Wait-and-see policy
  • Transanal endoscopic microsurgery
  • Rectal Neoplasms

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