Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConsorci Sanitari de Terrassa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
rectal cancer radiotherapy
RadiationConformal 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Symptomatic response after palliative radiotherapy (bleeding)
number of patients with bleeding ( worst, no change, better or without)
Time frame
two months afer the end of radiotherapy2
Symptomatic response after palliative radiotherapy (pain)
number of patients with pain ( worst, no change, better or without)
Time frame
two months afer the end of radiotherapy3
Gastrointestinal toxicity after the end of radiotherapy
Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale
Time frame
two months afer the end of radiotherapy4
Genitourinary toxicity after the end of radiotherapy
Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.
Time frame
two months afer the end of radiotherapySecondary outcomes
1
palliative colostomy after the end of palliative radiotherapy
number of patients with colostomy
Time frame
two months afer the end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov