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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03853733
Other study ID # ONCORTCST2019-2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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