Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03853733

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this 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.

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.

Who can participate

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

Inclusion criteria

  • 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
  • Patients with = or > 18 years old
  • Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy

Exclusion criteria

  • Patients with a non rectum or sigma colo-rectal cancer.
  • Patients with <18 years old.
  • Patients treated with concurrent chemotherapy
  • Patients candidates for surgical resection after radiotherapy

Treatment and study plan

rectal cancer radiotherapy

Radiation

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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.

Secondary outcomes

  1. palliative colostomy after the end of palliative radiotherapy

    Time frame: two months afer the end of radiotherapy

    number of patients with colostomy

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Lozano, MD

CONTACT

[email protected]

+34 937003690

Joan Lozano, MD

CONTACT

[email protected]

+34 937003690

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2019
Registry last updated
Mar 19, 2026

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.

Published trials that share one or more normalized conditions with this study.