Rectal CancerNCT03479814
Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)
A study testing IMRT-SIB plus sequential IG-RT boost in people with Rectal Cancer and Radiotherapy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Radiotherapy, Neoadjuvant Treatment
- What is being tested?
- IMRT-SIB plus sequential IG-RT boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- M1
- familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
- severe cardiopathy
- previous pelvic RT
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, 40138
Alessio G Morganti, MD, 0512143564 ext. +39, alessio.morganti2@unibo.it
About this study
Official title: AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
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
Read the 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.
- Conditions
- Rectal Cancer, Radiotherapy, Neoadjuvant Treatment
- Being tested
- IMRT-SIB plus sequential IG-RT boost
- Keywords
- rectal cancer, neoadjuvant chemoradiation, IMRT-SIB, adaptive radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT-SIB plus sequential IG-RT boostRadiation
| Study group | Role | What they receive |
|---|---|---|
| IMRT-SIB plus sequential IG-RT boost | Experimental | 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 Receives: Radiation: IMRT-SIB plus sequential IG-RT boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete pathological response (pCR)
pCR is defined as ypT0N0
Measured: 6 weeks
Secondary outcomes (5)
Acute toxicity
Acute toxicity is evaluated using CTCAE criteria
Measured: 6 months
Quality of Life (QoL)
QoL is evaluated using EORTC QoL questionnaire
Measured: 1 year
Late toxicity
Late toxicity is evaluated using CTCAE criteria
Measured: 1 year
Dosimetric advantage of GTV-boost reduction
Dosimetric advantage is evaluated using DVHs (Dose Volume Histograms)
Measured: 6 weeks
Evaluation of PET-response as predictive factor
Correlation between SUV (Standardized Uptake Value) and pathological response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Aug 2016
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G Morganti, MD, Principal investigator, Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479814
- Sponsor's protocol ID
- AIDA-RE-1
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
- ClinicalTrials.gov ID
- NCT03479814
- Acronym / sponsor ID
- AIDA-RE-1
- Conditions
- Rectal Cancer, Radiotherapy, Neoadjuvant Treatment
- Keywords
- rectal cancer, neoadjuvant chemoradiation, IMRT-SIB, adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Aug 2016
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT-SIB plus sequential IG-RT boost | Experimental | Radiation: IMRT-SIB plus sequential IG-RT boost45 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- M1
- familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
- severe cardiopathy
- previous pelvic RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRT-SIB plus sequential IG-RT boost | Radiation | IMRT-SIB plus sequential IG-RT boost |
Primary outcome
complete pathological response (pCR)
Time frame: 6 weeks
pCR is defined as ypT0N0
5 secondary outcomes
Acute toxicity
Time frame: 6 months
Quality of Life (QoL)
Time frame: 1 year
Late toxicity
Time frame: 1 year
Dosimetric advantage of GTV-boost reduction
Time frame: 6 weeks
Evaluation of PET-response as predictive factor
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessio G Morganti, MD principal investigator
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT-SIB plus sequential IG-RT boost in people with Rectal Cancer and Radiotherapy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessio G Morganti, MD (0512143564 ext. +39, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete pathological response (pCR) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.