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

IRCCS Azienda Ospedaliero-Universitaria di Bologna9 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer Radiotherapy Neoadjuvant Treatment

Interventions

IMRT-SIB plus sequential IG-RT boostRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital

Bologna, BO, Italy

RECRUITING

Outcomes

Primary Outcomes

complete pathological response (pCR)

pCR is defined as ypT0N0

Time frame: 6 weeks

Secondary Outcomes

Acute toxicity

Acute toxicity is evaluated using CTCAE criteria

Time frame: 6 months

Quality of Life (QoL)

QoL is evaluated using EORTC QoL questionnaire

Time frame: 1 year

Late toxicity

Late toxicity is evaluated using CTCAE criteria

Time frame: 1 year

Dosimetric advantage of GTV-boost reduction

Dosimetric advantage is evaluated using DVHs (Dose Volume Histograms)

Time frame: 6 weeks

Evaluation of PET-response as predictive factor

Correlation between SUV (Standardized Uptake Value) and pathological response

Time frame: 1 year

Central Contacts

Alessio G Morganti, MD

CONTACT

0512143564 alessio.morganti2@unibo.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.