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Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer Stage II, Rectal Cancer Stage III

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Trial Information

Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma


The criteria for application of RCT is the distance of the tumor from mesorectal fascia in
preoperative MRI of the pelvis. In case of a T 4 tumor or a tumor with a distance of 1mm of
less form mesorectal fascia long-course radiochemotherapy is applied followed by surgery, in
all other cases primary surgery is done.


Inclusion Criteria:



- Patients with histologically confirmed invasive carcinoma of the rectum infiltrating
beyond the submucosa (cT3, cT2N+, cM0)

- Elective surgery

- Fit for surgery

- Preoperative MRI of pelvis

Exclusion Criteria:

- uT1 Tumors

- provided for local excision

- previous or synchronous malignant tumors (except squamous and basal cell carcinoma of
the skin and carcinoma in situ of the cervix)

- previous irradiation of the pelvis

- ulcerative colitis or Crohn's disease

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Locoregional recurrence rate

Outcome Time Frame:

Five year

Safety Issue:

No

Authority:

Ethic committee Rheinland Pfalz: Mainz/Germany

Study ID:

Ocumstudy 19.08.2009

NCT ID:

NCT01325649

Start Date:

February 2009

Completion Date:

December 2015

Related Keywords:

  • Rectal Cancer Stage II
  • Rectal Cancer Stage III
  • rectal cancer
  • MRI
  • selective preoperative radiochemotherapy
  • involvement of circumferential resection margin
  • locoregional recurrence rate
  • Carcinoma
  • Rectal Neoplasms

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