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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Palliative Short-Course Radiotherapy in Rectal Cancer

NCT02639403

Rectal Neoplasms

COMPLETED PHASE2

THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy

NCT04815694

Neoadjuvant Chemoradiotherapy Locally Advanced Rectal Cancer Pathological Complete Response

UNKNOWN NA

Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases

NCT01157806

Rectal Cancer

UNKNOWN PHASE2

High Dose Radiotherapy for the Treatment of Rectal Cancer

NCT03541304

Rectal Cancer

COMPLETED

Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers

NCT03200249

Advanced Rectal Cancers

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No