Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

Toxicity Clinical Trial

Official title:

Phase II Study on Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03975452
• Other study ID #: 8/07 PAR ComEt CBM
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2007
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Toxicity

Intervention

Radiation:
• Reduced radiation volumes
Patient treated with reduced radiation volumes with the exclusion of elective pelvic nodal irradiation

Locations

Country	Name	City	State
Italy	Michele Fiore	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pathological complete response (pCR)	All study sample characteristics will be summarized with descriptive statistics	36 months
Secondary	The local control (LC) rate	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.	36 months
Secondary	The overall survival (OS)	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.	36 months
Secondary	The disease-free survival (DFS)	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.	36 months