Clinical trial NCT01444495: Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
Official title: Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
radiotherapy
overall survival
recurrence rate
downstaging
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: local and systemic recurrence rate
timeFrame: 5 years
Secondary outcomes:
measure: radical resections rate (R0)
timeFrame: 1 month
measure: sphincter saving (sparing) procedures
timeFrame: 1 month
measure: overall survival
timeFrame: 5 years
measure: downstaging of rectal cancer
timeFrame: 1 month
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: First Department of Surgery
state: Malopolska
Study officials:
affiliation: First Department of General Surgery, Jagiellonian University
name: Jan Kulig, Prof.
role: STUDY_CHAIR
affiliation: First Department of General Surgery, Jagiellonian University
name: Radoslaw Pach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer--treatment results at 5-year follow-up. Langenbecks Arch Surg. 2012 Jun;397(5):801-7. doi: 10.1007/s00423-011-0890-8. Epub 2011 Dec 15.
citation: Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Erratum to: Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer-treatment results at 5 year follow-up. Langenbecks Arch Surg. 2019 Sep;404(Suppl 1):19-20. doi: 10.1007/s00423-012-0940-x. No abstract available.
citation: Pach R, Sierzega M, Szczepanik A, Popiela T, Richter P. Preoperative radiotherapy 5 x 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial. Radiother Oncol. 2021 Nov;164:268-274. doi: 10.1016/j.radonc.2021.10.006. Epub 2021 Oct 13.
citation: Pach R, Richter P, Sierzega M, Papp N, Szczepanik A. Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up. Biomedicines. 2021 Jun 24;9(7):725. doi: 10.3390/biomedicines9070725.
citation: Pach R, Szczepanik AM, Sierzega M, Daniluk M, Richter P. Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial. Langenbecks Arch Surg. 2022 Nov;407(7):2969-2980. doi: 10.1007/s00423-022-02603-8. Epub 2022 Jul 4.