Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03975452
Recruitment Status : Active, not recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Fiore, Campus Bio-Medico University

Brief Summary:
The study outlines a clinical prospective protocol consisting of preoperative chemoradiation in locally advanced rectal cancer, without elective pelvic nodal irradiation. The proposal to exclude lateral spaces from the target volume is based on the assumption that the radiological evidence of recurrence in the lateral lymph nodes is shown to be below 5%. In the study all patients underwent an accurate pre-treatment work-up including total body CT, pelvic MRI and 18-fluorodeoxyglucose PET/CT, in order to include patients without evidence of disease in lateral lymph nodes. The primary endpoint of the study was the reduction of gastrointestinal toxicity; secondary endpoints were the pathological complete response (pCR), the local control (LC) rate, the overall survival (OS) and the disease-free survival (DFS).

Condition or disease Intervention/treatment Phase
Toxicity Radiation: Reduced radiation volumes Not Applicable

Detailed Description:
Patients affected by histologically proven rectal cancer were considered for enrollment in a prospective protocol that included preoperative CRT and surgical treatment. All patients underwent pre-treatment work-up (clinical examination, pancolonoscopy with biopsy, total body CT scan, pelvic MRI, and whole body 18-fluorodeoxyglucose PET/CT scan). Eligible patients had primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes. Additional eligibility criteria included performance status as well as liver, kidney, and bone marrow function that allowed for long-course CRT, older than 18 years, and no distant metastases.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer
Actual Study Start Date : November 2007
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Primary resectable cT2-low lying-T3, N0-N1 rectal tumour
Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes.
Radiation: Reduced radiation volumes
Patient treated with reduced radiation volumes with the exclusion of elective pelvic nodal irradiation




Primary Outcome Measures :
  1. The reduction of gastrointestinal (GI) toxicity [ Time Frame: 36 months ]
    The study is planned to obtain a 66% reduction in acute grade 3 or higher GI side-effects


Secondary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: 36 months ]
    All study sample characteristics will be summarized with descriptive statistics

  2. The local control (LC) rate [ Time Frame: 36 months ]
    The LC will be calculated by the Kaplan-Meier method. Evaluation of differences will be performed with the log-rank test. Survival will be censored at the time of the last follow-up or death. A two-sided P value of 0.05 will be considered significant.

  3. The overall survival (OS) [ Time Frame: 36 months ]
    The OS will be calculated by the Kaplan-Meier method. Evaluation of differences will be performed with the log-rank test. Survival will be censored at the time of the last follow-up or death. A two-sided P value of 0.05 will be considered significant.

  4. The disease-free survival (DFS) [ Time Frame: 36 months ]
    The DFS will be calculated by the Kaplan-Meier method. Evaluation of differences will be performed with the log-rank test. Survival will be censored at the time of the last follow-up or death. A two-sided P value of 0.05 will be considered significant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes
  • No distant metastases

Exclusion Criteria:

  • Evidence of disease in lateral lymph nodes
  • Distant metastases

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): NCT03975452


Locations
Layout table for location information
Italy
Michele Fiore
Rome, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Layout table for investigator information
Principal Investigator: Lucio Trodella, Prof Campus Bio-Medico University

Layout table for additonal information
Responsible Party: Michele Fiore, MD, Researcher, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT03975452     History of Changes
Other Study ID Numbers: 8/07 PAR ComEt CBM
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases