Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radoslaw Pach, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01444495
First received: September 29, 2011
Last updated: June 15, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Radiation: Preoperative radiotherapy
Procedure: Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • local and systemic recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rate of local and sytemic recurrences in patients included to the protocol.


Secondary Outcome Measures:
  • radical resections rate (R0) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Rate of R0, R1 and R2 procedures according to Hermanek.

  • sphincter saving (sparing) procedures [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Rate of sphincter saving operations in both arms.

  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival and disease specific survival at 5 years follow-up

  • downstaging of rectal cancer [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging


Enrollment: 154
Study Start Date: January 1999
Study Completion Date: December 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short time interval
Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
Radiation: Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Other Name: Neoadjuvant radiotherapy
Procedure: Surgery
Total mesorectal excision of rectal cancer
Other Name: Operative treatment
Experimental: Long time interval
Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
Radiation: Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Other Name: Neoadjuvant radiotherapy
Procedure: Surgery
Total mesorectal excision of rectal cancer
Other Name: Operative treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444495

Locations
Poland
1st Department of General Surgery
Cracow, Malopolska, Poland, 31-501
Sponsors and Collaborators
Jagiellonian University
Investigators
Study Chair: Jan Kulig, Prof. 1st Department of General Surgery, Jagiellonian University
Principal Investigator: Radoslaw Pach, Ph.D. 1st Department of General Surgery, Jagiellonian University
  More Information

Publications:
Responsible Party: Radoslaw Pach, Assisstant Professor, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01444495     History of Changes
Other Study ID Numbers: Cracow Rectal Cancer Trial
Study First Received: September 29, 2011
Last Updated: June 15, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
rectal cancer
radiotherapy
overall survival
recurrence rate
downstaging

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 28, 2014