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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03479814

Enrollment

Registered

2018-03-27

Start date

2016-08-01

Completion date

2019-01-01

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoadjuvant Treatment, Radiotherapy, Rectal Cancer

Keywords

rectal cancer, neoadjuvant chemoradiation, IMRT-SIB, adaptive radiotherapy

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.

Interventions

RADIATIONIMRT-SIB plus sequential IG-RT boost

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
complete pathological response (pCR)	6 weeks	pCR is defined as ypT0N0

Secondary

Measure	Time frame	Description
Acute toxicity	6 months	Acute toxicity is evaluated using CTCAE criteria
Quality of Life (QoL)	1 year	QoL is evaluated using EORTC QoL questionnaire
Late toxicity	1 year	Late toxicity is evaluated using CTCAE criteria
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

Countries

Italy

Contacts

Primary ContactAlessio G Morganti, MD

alessio.morganti2@unibo.it0512143564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026