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Completed

NCT Number: NCT01444495

Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Department of Surgery

Krakow, Malopolska, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative radiotherapy

Radiation

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

Other names: Neoadjuvant radiotherapy

Surgery

Procedure

Total mesorectal excision of rectal cancer

Other names: Operative treatment

Primary outcomes

  1. local and systemic recurrence rate

    Time frame: 5 years

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

Secondary outcomes

  1. radical resections rate (R0)

    Time frame: 1 month

    Rate of R0, R1 and R2 procedures according to Hermanek.

  2. sphincter saving (sparing) procedures

    Time frame: 1 month

    Rate of sphincter saving operations in both arms.

  3. overall survival

    Time frame: 5 years

    Overall survival and disease specific survival at 5 years follow-up

  4. downstaging of rectal cancer

    Time frame: 1 month

    Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
1999
Primary completion
2008
Study completion
2010
First posted
Sep 30, 2011
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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