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Palliative Short-Course Radiotherapy in Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02639403
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Lorenzo Fuccio, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Radiation: Conformal three-dimensional Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palliative Short-Course Radiotherapy in Rectal Cancer: A Phase II Study
Study Start Date : October 2003
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: RT for Obstructing Rectal Cancer
Conformal three-dimensional RT was planned (3D-RT) in patients with obstructing rectal cancer not amenable for curative resection
Radiation: Conformal three-dimensional Radiotherapy
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.




Primary Outcome Measures :
  1. Change of the obstructive symptoms [ Time Frame: 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 Outcome Measures :
  1. Change of the overall symptoms [ Time Frame: 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. ]
  2. Change of the tumor mass volume [ Time Frame: 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. ]
  3. Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria v4.0 [ Time Frame: 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. ]
  4. Overall survival [ Time Frame: At the end of follow-up (3 years after RT) or until death of patient ]
  5. Obstruction/colostomy-free survival [ Time Frame: At the end of follow-up (3 years after RT) or until death of patient ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639403


Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Study Director: Alessio G Morganti, Professor Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy
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Responsible Party: Lorenzo Fuccio, Associate Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02639403    
Other Study ID Numbers: 001
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Keywords provided by Lorenzo Fuccio, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Rectal cancer
Radiotherapy
Occlusion
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases