HEAD AND NECK CANCERPhase 3NCT01124409
Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
A Phase 3 study testing EPID Verification and CBCT verification in people with HEAD AND NECK CANCER and CARCINOMA OROPHARYNX, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HEAD AND NECK CANCER, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS
- What is being tested?
- EPID Verification and CBCT verification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2009to Aug 2011
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
- Informed Consent
- KPS score > 70
Who cannot join
- Uncontrolled medical comorbidity
- Not ready for follow up
- Previous cancer directed therapy
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, New Delhi, 110029
About this study
Official title: Randomised Clinical Phase III Study of Radiotherapy Dose, Volume Evaluation for 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Squamous Cell Carcinoma
This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.
Read the detailed description
Aims and Objectives
- To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT.
- To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients.
- To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
- To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.
- Being tested
- EPID Verification, CBCT verification
- Keywords
- IGRT, 3DCRT, EPID, CBCT, HNSCC
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPID VerificationRadiation
Also called EPID, 3DCRT, HNSCC
Set up error verification and correction by EPID
CBCT verificationRadiation
Also called CBCT, IGRT, HNSCC
Setup error verification and correction by CBCT
| Study group | Role | What they receive |
|---|---|---|
| 3DCRT with EPID | Active comparator | this patients randomised to this arm will be planned by 3DCRT and during treatment setup error will be identified and corrected by weekly EPID if error >3mm.Weekly CBCT will be done for this arm to note the setup error but will not be corrected. Receives: Radiation: EPID Verification |
| IGRT with CBCT | Active comparator | The patients randomised to this arm will be planned by 3DCRT and set up error during RT will be verified by CBCT and error corrected if >3mm.Weekly EPID will be done for setup error documentation but no correction based on EPID in this arm. Receives: Radiation: CBCT verification |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
The advent of CBCT has increased the verification of Radiation treatment delivery but whether it leads to significant change in tumour response or toxicities when compared to 3D Conformal Radiotherapy without CBCT verification is not known.This study will give insights into this question.
Measured: Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011
Secondary outcomes (2)
To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer
Assessment will be done by RTOG scoring criteria
Measured: assessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011
To find out the different doses received by target and organs at risk during the various phases of adaptive RT.
Measured: last measurement by AUG 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEAD AND NECK CANCERStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- BIDHU K MOHANTI, MD, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124409
- Sponsor's protocol ID
- 3DIGHNC
- Status last verified
- Jun 2011
- First submitted
- 13 May 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Phase III Study of Radiotherapy Dose, Volume Evaluation for 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01124409
- Acronym / sponsor ID
- 3DIGHNC
- Keywords
- IGRT, 3DCRT, EPID, CBCT, HNSCC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 May 2010 (estimated)
- 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.
This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.
Detailed description
Aims and Objectives
- To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT.
- To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients.
- To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
- To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3DCRT with EPID | Active comparator | Radiation: EPID Verificationthis patients randomised to this arm will be planned by 3DCRT and during treatment setup error will be identified and corrected by weekly EPID if error >3mm.Weekly CBCT will be done for this arm to note the setup error but will not be corrected. |
| IGRT with CBCT | Active comparator | Radiation: CBCT verificationThe patients randomised to this arm will be planned by 3DCRT and set up error during RT will be verified by CBCT and error corrected if >3mm.Weekly EPID will be done for setup error documentation but no correction based on EPID in this arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
- Informed Consent
- KPS score > 70
Key exclusion criteria (3 listed)
- Uncontrolled medical comorbidity
- Not ready for follow up
- Previous cancer directed therapy
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 |
|---|---|---|
| EPID VerificationAlso: EPID, 3DCRT, HNSCCSet up error verification and correction by EPID | Radiation | 3DCRT with EPID |
| CBCT verificationAlso: CBCT, IGRT, HNSCCSetup error verification and correction by CBCT | Radiation | IGRT with CBCT |
Primary outcome
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
Time frame: Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011
The advent of CBCT has increased the verification of Radiation treatment delivery but whether it leads to significant change in tumour response or toxicities when compared to 3D Conformal Radiotherapy without CBCT verification is not known.This study will give insights into this question.
2 secondary outcomes
To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer
Time frame: assessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011
To find out the different doses received by target and organs at risk during the various phases of adaptive RT.
Time frame: last measurement by AUG 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
BIDHU K MOHANTI, MD study chair
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EPID Verification and CBCT verification in people with HEAD AND NECK CANCER and CARCINOMA OROPHARYNX, run by All India Institute of Medical Sciences at 1 site in India.
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 3 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 23 Jun 2011. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the early tumour response between 3DCRT and IGRT in head and neck cancer. (time frame: Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011). 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 23 Jun 2011.