Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

NCT01444495 | Completed

• 1 other identifier: Cracow Rectal Cancer Trial
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; radiotherapy; overall survival; recurrence rate; downstaging

Outcome Measures

Primary Outcomes (1)

• local and systemic recurrence rate

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

  5 years

Secondary Outcomes (4)

• radical resections rate (R0)

  1 month

• sphincter saving (sparing) procedures

  1 month

• overall survival

  5 years

• downstaging of rectal cancer

  1 month

Study Arms (2)

Short time interval

ACTIVE COMPARATOR

Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.

Radiation: Preoperative radiotherapy; Procedure: Surgery

Long time interval

EXPERIMENTAL

Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.

Radiation: Preoperative radiotherapy; Procedure: Surgery

Interventions

Preoperative radiotherapy RADIATION

Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)

Also known as: Neoadjuvant radiotherapy

Long time interval; Short time interval

Surgery PROCEDURE

Total mesorectal excision of rectal cancer

Also known as: Operative treatment

Long time interval; Short time interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed rectal cancer
• tumor localised in middle or lower rectum
• age \> 18 years
• locally advanced cancer

You may not qualify if:

• previous pelvis radiotherapy
• lack of patient's consent

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

First Department of Surgery

Krakow, Malopolska, 31-501, Poland

Location

Related Publications (5)

• 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.

  PMID: 22170083 RESULT

• 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.

  PMID: 22398435 RESULT

• 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.

  PMID: 34653526 RESULT

• 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.

  PMID: 34202691 RESULT

• 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.

  PMID: 35788774 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Jan Kulig, Prof.

  First Department of General Surgery, Jagiellonian University

  STUDY CHAIR

• Radoslaw Pach, Ph.D.

  First Department of General Surgery, Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: January 1, 1999
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2010
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

PL (1)