Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444495
• Other study ID #: Cracow Rectal Cancer Trial
• Status: Completed
• Phase: N/A
• Start date: January 1999
• Est. completion date: December 2010

Study information

• Verified date: February 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)

Procedure:
• Surgery
Total mesorectal excision of rectal cancer

Locations

Country	Name	City	State
Poland	First Department of Surgery	Krakow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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/s004 — View 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. Ep — View 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 — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local and systemic recurrence rate	Rate of local and sytemic recurrences in patients included to the protocol.	5 years
Secondary	radical resections rate (R0)	Rate of R0, R1 and R2 procedures according to Hermanek.	1 month
Secondary	sphincter saving (sparing) procedures	Rate of sphincter saving operations in both arms.	1 month
Secondary	overall survival	Overall survival and disease specific survival at 5 years follow-up	5 years
Secondary	downstaging of rectal cancer	Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging	1 month