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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853733
• Other study ID #: ONCORTCST2019-2
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic response after palliative radiotherapy (bleeding)	number of patients with bleeding ( worst, no change, better or without)	two months afer the end of radiotherapy
Primary	Symptomatic response after palliative radiotherapy (pain)	number of patients with pain ( worst, no change, better or without)	two months afer the end of radiotherapy
Primary	Gastrointestinal toxicity after the end of radiotherapy	Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale	two months afer the end of radiotherapy
Primary	Genitourinary toxicity after the end of radiotherapy	Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.	two months afer the end of radiotherapy
Secondary	palliative colostomy after the end of palliative radiotherapy	number of patients with colostomy	two months afer the end of radiotherapy