Cancer of Head and NeckIGRTNCT01853670
Adaptive Radiation Therapy for Head & Neck Cancer Patients
A study testing concurrent chemo + IGRT and neoadjuvant chemo + IGRT in people with Cancer of Head and Neck, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- concurrent chemo + IGRT and neoadjuvant chemo + IGRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2015
- 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
- Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
- Patients should meet at least one of the following criteria:
- Locally advanced cancer (T3-T4 and/or N2-N3)
- Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
- Significant expected weight loss.
Who cannot join
- Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
- Poor renal function (inability to undergo a CT with IV contrast)
- Previous radiation therapy to the head and neck.
- Inability to tolerate prolonged immobilization.
- Children and women who are pregnant or decline to use contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
Official title: Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
Read the detailed description
The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.
- Conditions
- Cancer of Head and Neck
- Being tested
- concurrent chemo + IGRT, neoadjuvant chemo + IGRT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent chemo + IGRTRadiation
neoadjuvant chemo + IGRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| definitive radiation + concomitant chemo | Experimental | Concurrent chemo + IGRT:
These patients will have chemotherapy during the time of radiation treatment Receives: Radiation: concurrent chemo + IGRT |
| neoadjuvant chemo | Experimental | Neoadjuvant chemo + IGRT:
These patients will have chemotherapy prior to other radiation treatment. Receives: Radiation: neoadjuvant chemo + IGRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical patient response
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
Measured: From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
Secondary outcomes (1)
Patient quality of life
This will be assessed using the: Fact Head \& Neck form at baseline, and weekly throughout radiation treatment.
Measured: During radiation therapy (7-9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startAug 2009
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken Hu, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853670
- Sponsor's protocol ID
- 167-08
- Acronym
- IGRT
- Status last verified
- Sep 2014
- First submitted
- 25 Feb 2013
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
- ClinicalTrials.gov ID
- NCT01853670
- Acronym / sponsor ID
- IGRT / 167-08
- Conditions
- Cancer of Head and Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 May 2013 (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.
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
Detailed description
The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| definitive radiation + concomitant chemo | Experimental | Radiation: concurrent chemo + IGRTConcurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment |
| neoadjuvant chemo | Experimental | Radiation: neoadjuvant chemo + IGRTNeoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
- Patients should meet at least one of the following criteria:
Key exclusion criteria (5 listed)
- Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
- Poor renal function (inability to undergo a CT with IV contrast)
- Previous radiation therapy to the head and neck.
- Inability to tolerate prolonged immobilization.
- Children and women who are pregnant or decline to use contraception.
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 |
|---|---|---|
| concurrent chemo + IGRT | Radiation | definitive radiation + concomitant chemo |
| neoadjuvant chemo + IGRT | Radiation | neoadjuvant chemo |
Primary outcome
Clinical patient response
Time frame: From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
1 secondary outcome
Patient quality of life
Time frame: During radiation therapy (7-9 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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.
Ken Hu, MD principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concurrent chemo + IGRT and neoadjuvant chemo + IGRT in people with Cancer of Head and Neck, run by Beth Israel Medical Center at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Mar 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical patient response (time frame: From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).). 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 30 Mar 2015.