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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: rectal cancer radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic response after palliative radiotherapy (bleeding) | number of patients with bleeding ( worst, no change, better or without) | two months afer the end of radiotherapy | 
| Symptomatic response after palliative radiotherapy (pain) | number of patients with pain ( worst, no change, better or without) | two months afer the end of radiotherapy | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| palliative colostomy after the end of palliative radiotherapy | number of patients with colostomy | two months afer the end of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative radiotherapy, rectal bleeding, hypofractionated radiotherapy