Ireland
--:--IST
Recruiting Observational

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

NCT03853733 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2016-10-01
Last updated
2026-03-19

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

rectal cancer radiotherapy

rectal 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Consorci Sanitari de Terrassa Terrassa Catalonia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03853733 on ClinicalTrials.gov ↗ ← All trials in Spain