Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

Conditions

Rectal Cancer Stage II, Rectal Cancer Stage III

Keywords

rectal cancer, MRI, selective preoperative radiochemotherapy, involvement of circumferential resection margin, locoregional recurrence rate

Brief summary

The objective of the study is to provide proof that a MRI based preoperative radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to high risk patients without increase of locoregional recurrence rate and decrease of overall survival provided there is a high quality of mesorectal excision.

Detailed description

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.

Jii Bum Lee, Han Sang Kim, Inkyung Jung, Sang Joon Shin, Seung‐Hoon Beom et al. (18 authors)

Trials2020-04-0711 citations

10.1186/s13063-020-04266-6

[Lymph node dissection after primary surgery and neoadjuvant radiochemotherapy of rectal cancer. Interim analysis of a multicenter prospective observational study (OCUM)].

Kreis ME, Maurer CA, Ruppert R, Ptok H, Strassburg J, Junginger T, Merkel S, Hermanek P.

2015-12-014 citations

10.1007/s00104-015-0062-4

Rectal cancer treatment without neoadjuvant chemoradiation based on preoperative magnetic resonance imaging: Determinants of surgical quality in the German OCUM study.

Martin E. Kreis, Joachim Straßburg, R. Ruppert, Henry Ptok, T Junginger et al. (7 authors)

Journal of Clinical Oncology2014-01-20

10.1200/jco.2014.32.3_suppl.526

Interventions

PROCEDUREtotal mesorectal excision / long course radiochemotherapy

long course 5-FU based radiochemotherapy before total mesorectal excision

RADIATIONlong course 5-FU bases radiochemotherapy

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Locoregional recurrence rate	Five year

Secondary

Measure	Time frame	Description
Rate of involvement of circumferential resection margin (pCRM positive of resected specimens	postoperative	pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.

Countries

Germany

Outcome results

None listed