Clinical trial NCT03853733: Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
Official title: Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Keywords: palliative radiotherapy
rectal bleeding
hypofractionated radiotherapy
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis.

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.

Eligibility criteria: 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 outcomes:
measure: Symptomatic response after palliative radiotherapy (bleeding)
timeFrame: two months afer the end of radiotherapy
measure: Symptomatic response after palliative radiotherapy (pain)
timeFrame: two months afer the end of radiotherapy
measure: Gastrointestinal toxicity after the end of radiotherapy
timeFrame: two months afer the end of radiotherapy
measure: Genitourinary toxicity after the end of radiotherapy
timeFrame: two months afer the end of radiotherapy
Secondary outcomes:
measure: palliative colostomy after the end of palliative radiotherapy
timeFrame: two months afer the end of radiotherapy
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Catalonia
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Joan Lozano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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