Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03853733
Enrollment
50
Registered
2019-02-26
Start date
2016-10-01
Completion date
2027-03-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

palliative radiotherapy, rectal bleeding, hypofractionated radiotherapy

Brief 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.

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.

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.

Sponsors

Consorci Sanitari de Terrassa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Symptomatic response after palliative radiotherapy (bleeding)two months afer the end of radiotherapynumber of patients with bleeding ( worst, no change, better or without)
Symptomatic response after palliative radiotherapy (pain)two months afer the end of radiotherapynumber of patients with pain ( worst, no change, better or without)
Gastrointestinal toxicity after the end of radiotherapytwo months afer the end of radiotherapyGastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale
Genitourinary toxicity after the end of radiotherapytwo months afer the end of radiotherapyGenitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.

Secondary

MeasureTime frameDescription
palliative colostomy after the end of palliative radiotherapytwo months afer the end of radiotherapynumber of patients with colostomy

Countries

Spain

Contacts

CONTACTJoan Lozano, MD
jlozano@cst.cat+34 937003690
PRINCIPAL_INVESTIGATORJoan Lozano, MD

Consorci Sanitari de Terrassa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026