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Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

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Trial Information

Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer


The treatment group comprises patients with locally advanced rectal cancer who were operated
on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on
survival has been systematically collected using national census registry. Patients are
qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with
different time interval between radiotherapy and surgery: one subgroup consists of patients
operated on 7-10 days after the end of irradiation, the second subgroup consists of patients
operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and
localization, distal and circumferential resection margins, number of resected lymph nodes.
3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the
tumor before and after preoperative radiotherapy.


Inclusion Criteria:



- histologically confirmed rectal cancer

- tumor localised in middle or lower rectum

- age > 18 years

- locally advanced cancer

Exclusion Criteria:

- previous pelvis radiotherapy

- lack of patient's consent

- lack of possibility to begin radiotherapy during 14 days after inclusion to the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local and systemic recurrence rate

Outcome Description:

Rate of local and sytemic recurrences in patients included to the protocol.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jan Kulig, Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

1st Department of General Surgery, Jagiellonian University

Authority:

Poland: Ministry of Health

Study ID:

Cracow Rectal Cancer Trial

NCT ID:

NCT01444495

Start Date:

January 1999

Completion Date:

December 2010

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • radiotherapy
  • overall survival
  • recurrence rate
  • downstaging
  • Rectal Neoplasms

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