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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Neoadjuvant Treatment; Radiotherapy; Rectal Cancer

Treatments: Radiation: IMRT-SIB plus sequential IG-RT boost

Study type: Interventional

Funder types: Other

Identifiers

NCT03479814

AIDA-RE-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

IMRT-SIB plus sequential IG-RT boost

Experimental group

Description:

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

Treatment:

Radiation: IMRT-SIB plus sequential IG-RT boost