Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)

Study Overview
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Brief Summary
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Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy

Detailed Description
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AIDA-RE-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. In neoadjuvant setting, patients are treated with standard chemotherapy plus experimental radiotherapy. The total dose to clinical target volume (CTV, rectum and locoregional lymph nodes) is 45 Gy, with a concomitant boost of 5 Gy to gross tumor volume (GTV), delivered with IMRT-SIB (intensity modulated radiotherapy-simultaneous integrated boost) technique in 25 fractions. After 2 weeks of treatment, patients are evaluated with 18 FDG-PET and sequential boost of 5 Gy (in 2 fractions) is planned.

Official Title
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AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer

Conditions
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Rectal Cancer, Radiotherapy, Neoadjuvant Treatment

Intervention / Treatment
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* Radiation: IMRT-SIB plus sequential IG-RT boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved M0 ECOG 0-2 Exclusion Criteria: M1 familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease severe cardiopathy previous pelvic RT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT-SIB plus sequential IG-RT boost<br>45 Gy plus 5 Gy concomitant boost are delivered to rectum and locoregional lymphnodes (25 fractions); sequential IG-RT (imaging guided-radiotherapy) boost of 5 Gy in 2 fractions is planned with 18-FDG-PET | Radiation: IMRT-SIB plus sequential IG-RT boost<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete pathological response (pCR) | pCR is defined as ypT0N0 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Acute toxicity is evaluated using CTCAE criteria | 6 months | 
| Quality of Life (QoL) | QoL is evaluated using EORTC QoL questionnaire | 1 year | 
| Late toxicity | Late toxicity is evaluated using CTCAE criteria | 1 year | 
| Dosimetric advantage of GTV-boost reduction | Dosimetric advantage is evaluated using DVHs (Dose Volume Histograms) | 6 weeks | 
| Evaluation of PET-response as predictive factor | Correlation between SUV (Standardized Uptake Value) and pathological response | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT-SIB, rectal cancer, neoadjuvant chemoradiation, adaptive radiotherapy