Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer

Last updated: October 3, 2024
Sponsor: Consorci Sanitari de Terrassa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

rectal cancer radiotherapy

Clinical Study ID

NCT03853733
ONCORTCST2019-2
  • Ages > 18
  • All Genders

Study Summary

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Eligibility Criteria

Inclusion

Inclusion criteria :

  1. Patients with rectal or sigmoidal cancer who were not candidates for surgicalresection because advanced age, comorbidities, or multiple synchronous metastases atthe time of diagnosis

  2. Patients with = or > 18 years old

  3. Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy

Exclusion

Exclusion criteria:

  1. Patients with a non rectum or sigma colo-rectal cancer.

  2. Patients with <18 years old.

  3. Patients treated with concurrent chemotherapy

  4. Patients candidates for surgical resection after radiotherapy

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: rectal cancer radiotherapy
Phase:
Study Start date:
October 01, 2016
Estimated Completion Date:
March 01, 2025

Study Description

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.

Patients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.

A conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Symptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale.

Connect with a study center

  • Consorci Sanitari de Terrassa

    Terrassa, Catalonia 08227
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.