Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rectal cancer radiotherapy.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Symptomatic response after palliative radiotherapy (bleeding) [Time frame: two months afer the end of radiotherapy]
- Symptomatic response after palliative radiotherapy (pain) [Time frame: two months afer the end of radiotherapy]
- Gastrointestinal toxicity after the end of radiotherapy [Time frame: two months afer the end of radiotherapy]
- Genitourinary toxicity after the end of radiotherapy [Time frame: two months afer the end of radiotherapy]
Secondary outcome measures (1)
- palliative colostomy after the end of palliative radiotherapy [Time frame: two months afer the end of radiotherapy]
Eligibility criteria
Inclusion criteria
- 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
- Patients with = or > 18 years old
- Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy
Exclusion criteria
- Patients with a non rectum or sigma colo-rectal cancer.
- Patients with <18 years old.
- Patients treated with concurrent chemotherapy
- Patients candidates for surgical resection after radiotherapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Consorci Sanitari de Terrassa — Terrassa
Publications
- 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
Identifiers
NCT: NCT03853733 · ONCORTCST2019-2