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

Not Applicable

• Conditions: Rectal Cancer; Radiotherapy; Neoadjuvant Treatment
• Interventions: Radiation: IMRT-SIB plus sequential IG-RT boost

• Registration Number: NCT03479814
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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 Timeline

• Study Start: 2016-08-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT-SIB plus sequential IG-RT boost	IMRT-SIB plus sequential IG-RT boost	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

Primary Outcome Measures

Name	Time	Method
complete pathological response (pCR)	6 weeks	pCR is defined as ypT0N0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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