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

Recruiting

• Conditions: Rectal Cancer

• Registration Number: NCT03853733
• Lead Sponsor: Consorci Sanitari de Terrassa

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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-26
• Primary Completion: 2023-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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.
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

Secondary Outcome Measures

Name	Time	Method
palliative colostomy after the end of palliative radiotherapy	two months afer the end of radiotherapy	number of patients with colostomy

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Catalonia, Spain