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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479814
• Other study ID #: AIDA-RE-1
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2018
• Last updated: March 26, 2018
• Start date: August 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessio G Morganti, MD
• Phone: 0512143564
• Email: alessio.morganti2[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoadjuvant Treatment
• Radiotherapy
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete pathological response (pCR)	pCR is defined as ypT0N0	6 weeks
Secondary	Acute toxicity	Acute toxicity is evaluated using CTCAE criteria	6 months
Secondary	Quality of Life (QoL)	QoL is evaluated using EORTC QoL questionnaire	1 year
Secondary	Late toxicity	Late toxicity is evaluated using CTCAE criteria	1 year
Secondary	Dosimetric advantage of GTV-boost reduction	Dosimetric advantage is evaluated using DVHs (Dose Volume Histograms)	6 weeks
Secondary	Evaluation of PET-response as predictive factor	Correlation between SUV (Standardized Uptake Value) and pathological response	1 year