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

C

Consorci Sanitari de Terrassa

Status

Completed

Conditions

Rectal Cancer

Treatments

Radiation: rectal cancer radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT03853733
ONCORTCST2019-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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