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

Primary Purpose

Rectal Cancer, Radiotherapy, Neoadjuvant Treatment

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IMRT-SIB plus sequential IG-RT boost
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, neoadjuvant chemoradiation, IMRT-SIB, adaptive radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT-SIB plus sequential IG-RT boost

Arm 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

Outcomes

Primary Outcome Measures

complete pathological response (pCR)
pCR is defined as ypT0N0

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2018
Last Updated
March 26, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03479814
Brief Title
Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)
Official Title
AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (undefined)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Radiotherapy, Neoadjuvant Treatment
Keywords
rectal cancer, neoadjuvant chemoradiation, IMRT-SIB, adaptive radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMRT-SIB plus sequential IG-RT boost
Arm Type
Experimental
Arm 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
Intervention Type
Radiation
Intervention Name(s)
IMRT-SIB plus sequential IG-RT boost
Primary Outcome Measure Information:
Title
complete pathological response (pCR)
Description
pCR is defined as ypT0N0
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Acute toxicity
Description
Acute toxicity is evaluated using CTCAE criteria
Time Frame
6 months
Title
Quality of Life (QoL)
Description
QoL is evaluated using EORTC QoL questionnaire
Time Frame
1 year
Title
Late toxicity
Description
Late toxicity is evaluated using CTCAE criteria
Time Frame
1 year
Title
Dosimetric advantage of GTV-boost reduction
Description
Dosimetric advantage is evaluated using DVHs (Dose Volume Histograms)
Time Frame
6 weeks
Title
Evaluation of PET-response as predictive factor
Description
Correlation between SUV (Standardized Uptake Value) and pathological response
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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