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

March 18, 2026 updated by: Joan Lozano Galan, Consorci Sanitari de Terrassa

Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Catalonia
      • Terrassa, Catalonia, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria :

  1. Patients with rectal or sigmoidal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the 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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic response after palliative radiotherapy (bleeding)
Time Frame: two months afer the end of radiotherapy
number of patients with bleeding ( worst, no change, better or without)
two months afer the end of radiotherapy
Symptomatic response after palliative radiotherapy (pain)
Time Frame: two months afer the end of radiotherapy
number of patients with pain ( worst, no change, better or without)
two months afer the end of radiotherapy
Gastrointestinal toxicity after the end of radiotherapy
Time Frame: two months afer the end of radiotherapy
Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale
two months afer the end of radiotherapy
Genitourinary toxicity after the end of radiotherapy
Time Frame: two months afer the end of radiotherapy
Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.
two months afer the end of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
palliative colostomy after the end of palliative radiotherapy
Time Frame: two months afer the end of radiotherapy
number of patients with colostomy
two months afer the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Joan Lozano, MD, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • EP-1648: Palliative hipofractionated radiotherapy in non operable rectal cancer: preliminary results RSS Download PDF J. Lozano Galan, E. Rubio and J. Solé Radiotherapy and Oncology, 2018-04-01, Volume 127, Pages S887-S887

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCORTCST2019-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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