Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

NCT ID: NCT03975452

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2019-12-31

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).

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.

Conditions

Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reduced radiation volumes

Intervention Type: RADIATION

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

Interventions

Reduced radiation volumes

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Michele Fiore

MD, Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucio Trodella, Prof

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

Michele Fiore

Rome, , Italy

Countries

Italy

Other Identifiers

8/07 PAR ComEt CBM

Identifier Type: -

Identifier Source: org_study_id