Palliative Short-Course Radiotherapy in Rectal Cancer

NCT02639403 | Completed Phase 2

• 1 other identifier: 001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have been published more than two decades ago and were based on 2D conventional RT, which is nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the management of symptomatic rectal cancer are still lacking. The aim of this prospective study was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with symptomatic obstructive rectal cancer.

Conditions

Rectal Neoplasms

Keywords

Rectal cancer; Radiotherapy; Occlusion

Outcome Measures

Primary Outcomes (1)

• Change of the obstructive symptoms

  Clinical evaluation was performed before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

Secondary Outcomes (5)

• Change of the overall symptoms

  Before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

• Change of the tumor mass volume

  Before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

• Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria v4.0

  Before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.

• Overall survival

  At the end of follow-up (3 years after RT) or until death of patient

• Obstruction/colostomy-free survival

  At the end of follow-up (3 years after RT) or until death of patient

Study Arms (1)

RT for Obstructing Rectal Cancer

EXPERIMENTAL

Conformal three-dimensional RT was planned (3D-RT) in patients with obstructing rectal cancer not amenable for curative resection

Radiation: Conformal three-dimensional Radiotherapy

Interventions

Conformal three-dimensional Radiotherapy RADIATION

Conformal three-dimensional RT was planned (3D-RT) using the Oncentra-Masterplan treatment planning system (Nucletron B.V., Veenendaal, Netherland). Short course RT (total, 25 Gy; 5 fraction in 5 days) will be delivered with an isocentric four-field box technique.

RT for Obstructing Rectal Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) rectal adenocarcinoma with obstructive symptoms not amenable for curative treatment due to synchronous metastases or patient inoperable due to age and/or comorbidities;
• (ii) symptoms of colorectal obstruction (progressive constipation with abdominal pain arising from less than 2 months, vomiting and/or diarrhea) and/or signs of obstruction at radiological examinations (presence of air-fluid levels or the presence of distended colon upstream neoplastic stenosis of the rectum);
• (iii) candidates for derivative colostomy;
• (iv) bi-dimensionally measurable disease;
• (v) Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
• (vi) able to provide a written informed consent.

You may not qualify if:

• (i) RT within 6 months in the same anatomical area before the initiation of study treatment;
• (ii) clinically detectable ascites;
• (iii) pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Rectal Neoplasms; Bites and Stings

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Alessio G Morganti, Professor

  Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 24, 2015
• Study Start: October 1, 2003
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 24, 2015

Record last verified: 2015-12