ClinicalTrials.gg
RecruitingNCT03853733Updated Mar 19, 2026

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

An observational study in Rectal Cancer, sponsored by Consorci Sanitari de Terrassa. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Consorci Sanitari de Terrassa · Observational

From the registry’s dates

  • Started Oct 2016; still recruiting 10 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Rectal Cancer

Keywords

  • palliative radiotherapy
  • rectal bleeding
  • hypofractionated radiotherapy
03

In context

Rectal Neoplasms

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's planned enrollment of 50 is below the median of 161 across 498 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Radiationrectal cancer radiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Symptomatic response after palliative radiotherapy (bleeding)

    number of patients with bleeding ( worst, no change, better or without)

    Time frame: two months afer the end of radiotherapy

  2. Symptomatic response after palliative radiotherapy (pain)

    number of patients with pain ( worst, no change, better or without)

    Time frame: two months afer the end of radiotherapy

  3. Gastrointestinal toxicity after the end of radiotherapy

    Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale

    Time frame: two months afer the end of radiotherapy

  4. Genitourinary toxicity after the end of radiotherapy

    Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.

    Time frame: two months afer the end of radiotherapy

Secondary outcomes

  1. palliative colostomy after the end of palliative radiotherapy

    number of patients with colostomy

    Time frame: two months afer the end of radiotherapy

07

Study locations

1 of 1 sites recruiting
08

References and documents

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

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2016 (actual). Primary completion is estimated for Mar 2027, 125 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2019
First posted
Feb 26, 2019
StartActual
Oct 1, 2016
Primary completionEst.
Mar 1, 2027
CompletionEst.
Mar 1, 2027
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03853733
Lead sponsor
Consorci Sanitari de Terrassa
Responsible party
Joan Lozano Galan (Principal Investigator, Consorci Sanitari de Terrassa) — Principal investigator
First posted
Feb 26, 2019
Start date
Oct 1, 2016
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Mar 19, 2026

Study contacts

Joan Lozano, MD
Contact
jlozano@cst.cat
+34 937003690
Joan Lozano, MD
Contact
jlozano@comb.cat
+34 937003690
Joan Lozano, MD
principal investigator · Consorci Sanitari de Terrassa
View the source record on ClinicalTrials.gov ↗

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