An interventional study of Reduced radiation volumes in Toxicity, sponsored by Campus Bio-Medico University. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Campus Bio-Medico University · Not applicable, Interventional, and Treatment
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).
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 52 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
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
The reduction of gastrointestinal (GI) toxicity
The study is planned to obtain a 66% reduction in acute grade 3 or higher GI side-effects
Time frame: 36 months
Pathological complete response (pCR)
All study sample characteristics will be summarized with descriptive statistics
Time frame: 36 months
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.
Time frame: 36 months
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.
Time frame: 36 months
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.
Time frame: 36 months
Plan to share: No
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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