Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

NCT03975452 | Unknown

• 1 other identifier: 8/07 PAR ComEt CBM
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Toxicity

Outcome Measures

Primary Outcomes (1)

• The reduction of gastrointestinal (GI) toxicity

  The study is planned to obtain a 66% reduction in acute grade 3 or higher GI side-effects

  36 months

Secondary Outcomes (4)

• Pathological complete response (pCR)

  36 months

• The local control (LC) rate

  36 months

• The overall survival (OS)

  36 months

• The disease-free survival (DFS)

  36 months

Study Arms (1)

Primary resectable cT2-low lying-T3, N0-N1 rectal tumour

EXPERIMENTAL

Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes.

Radiation: Reduced radiation volumes

Interventions

Reduced radiation volumes RADIATION

Patient treated with reduced radiation volumes with the exclusion of elective pelvic nodal irradiation

Primary resectable cT2-low lying-T3, N0-N1 rectal tumour

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Evidence of disease in lateral lymph nodes
• Distant metastases

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Michele Fiore

Rome, 00128, Italy

Location

Study Officials

• Lucio Trodella, Prof

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Researcher

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: November 1, 2007
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)