Rectal CancerNCT03853733
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
An observational study of Rectal Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- rectal cancer radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2016to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Catalonia, 08227
Joan Lozano, MD, +34 937003690, jlozano@cst.cat
Joan Lozano, MD, 34 937003690, jlozano@cst.cat
About this study
Official title: 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.
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.
- Conditions
- Rectal Cancer
- Being tested
- rectal cancer radiotherapy
- Keywords
- palliative radiotherapy, rectal bleeding, hypofractionated radiotherapy
- Medical subject headings
- Rectal Neoplasms, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal cancer radiotherapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic response after palliative radiotherapy (bleeding)
number of patients with bleeding ( worst, no change, better or without)
Measured: two months afer the end of radiotherapy
Symptomatic response after palliative radiotherapy (pain)
number of patients with pain ( worst, no change, better or without)
Measured: two months afer the end of radiotherapy
Gastrointestinal toxicity after the end of radiotherapy
Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale
Measured: two months afer the end of radiotherapy
Genitourinary toxicity after the end of radiotherapy
Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.
Measured: two months afer the end of radiotherapy
Secondary outcomes (1)
palliative colostomy after the end of palliative radiotherapy
number of patients with colostomy
Measured: two months afer the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Oct 2016
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Lozano Galan, Consorci Sanitari de Terrassa
- Investigators
- Joan Lozano, MD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853733
- Sponsor's protocol ID
- ONCORTCST2019-2
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03853733
- Acronym / sponsor ID
- ONCORTCST2019-2
- Conditions
- Rectal Cancer
- Keywords
- palliative radiotherapy, rectal bleeding, hypofractionated radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectal cancer radiotherapyConformal 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. | Radiation | – |
Primary outcome
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)
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)
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
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.
1 secondary outcome
palliative colostomy after the end of palliative radiotherapy
Time frame: two months afer the end of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- BackgroundEP-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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan Lozano, MD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Lozano, MD (+34 937003690, jlozano@cst.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic response after palliative radiotherapy (bleeding) (time frame: two months afer the end of radiotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.