Head and Neck CancerNCT00490282
A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
A study testing Intensity Modulated Radiation Therapy and Adaptive Radiotherapy in people with Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharyngeal Cancer
- What is being tested?
- Intensity Modulated Radiation Therapy and Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.
- Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Who cannot join
- Patients who have undergone definitive resection of the primary tumor.
- Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
- Prior radiation therapy to the head and neck region.
- Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
- Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m2.
- Patients who have had prior chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.
Read the detailed description
The Study Scans and Tests:
IMRT is a type of 3-dimensional (3-D) radiation therapy that can focus radiation beams directly on the tumor itself. In this study, the IMRT is given using a standard radiation machine (ExaCT™ machine) that has a CT scanner attached to it. This machine is commonly used in patients with head and neck cancer. It gives the same radiation treatment as most of the other machines at M. D. Anderson. However, in addition to giving radiation treatments, it can also perform CT scans while the patient is in the same position on the treatment table, before the radiation therapy is given.
For this study, your standard of care daily CT scans will be used to help researchers adjust participants' radiation therapy, if necessary, on a weekly basis. In particular, the changes in normal tissue that are being studied are any changes in the salivary glands. An additional research related MRI scan will also be performed in this study, but the MRI scan will not be used to adjust participants' therapy. Researchers want to learn if MRI scanning may be able to help doctors in the future to adjust someone's treatment based on changes in a tumor (its features and size) in response to radiation.
Enrollment in the Study:
If you agree to take part in this study, you will receive IMRT according to the standard schedule (over 6 - 7 weeks). You will sign a separate consent form for the IMRT, and the procedure and its risks will be explained to you at that time.
CT Scans:
During this study, you will have a standard of care CT scan right before each IMRT treatment (over a 6-7 week period of time, depending on the exact schedule your doctor decides would be best for your treatment). These CT scans are standard of care, are used to make sure your treatment is being aimed properly, and would be performed whether you are participating on this trial or not. Once you are set up on the treatment table and are ready for radiation therapy, the table will be turned around and the CT scan will be performed. After the CT scan, which should take about 5-8 minutes, the table will be turned back around to the original position and the radiation treatment will be given to you. In total, about 30-33 CT scans will be performed for this study, depending on the exact number of treatments the doctor decides would be best for your therapy.
Routine MRI Scans:
Routine MRI scans of your head and neck will be performed before treatment (at Week 1) and after treatment (sometime during Weeks 12-14). These scans may be used for routine treatment planning and checking the status of the disease.
Study-Related MRI Scan:
An additional MRI scan will be done halfway through treatment (during Week 3). This MRI scan will be used to help researchers see if MRI scanning may be able to help doctors in the future to adjust someone's treatment based on changes in a tumor (its features and size) in response to radiation. In 15 participants, a repeat baseline study-related MRI scan will be done 48 hours to 1 week following the first routine MRI scan.
Modified Barium Swallow:
Your swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make your throat more visible in the x-rays. A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat.
MBS will be performed before you start radiation therapy, 4-6 months after the end of radiation therapy, and during your routine follow-up visits, 12 months (plus or minus 2 months), and 24 months (plus or minus 3 months).
Saliva Testing:
One reason IMRT is being used is to try to protect your parotid glands (the largest of the salivary glands) from receiving too much radiation. To check this, a study-related saliva test will be done. For this test, the amount of saliva your parotid glands create will be measured before treatment (within 7 days before Week 1) and at the last week of treatment (during Week 6 or 7). Do not eat or drink anything, or put anything in your mouth, for 1 hour before the saliva collections. You will be asked to let your saliva collect in your mouth for 5 minutes and then spit into a cup. After that, you will be given a mild citric acid solution (like lemon juice) to put in your mouth. You will let the saliva collect in your mouth for 5 minutes and then spit in a cup. Saliva testing will be performed under a separate protocol (LAB07-0050).
Length of Study:
If the disease gets worse or intolerable side effects occur, you will be taken off this study.
Follow-Up Visits:
At some time between Weeks 22 and 24, then every 3-4 months for up to 2 years after the last IMRT, you will return for follow-up visits. The amount of saliva your parotid glands create will be measured 6 weeks after radiation therapy, 4-6 months after radiation therapy, 1 year (plus or minus 2 months) after radiation therapy, and 2 years (plus or minus 3 months) after radiation therapy.
This is an investigational study. The ExaCT™ machine is FDA approved for use in IMRT in patients with head and neck cancer. Researchers are using this standard of care CT Scan for routine quality assurance to make sure your treatment is given correctly. Up to 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer, Oropharyngeal Cancer
- Being tested
- Intensity Modulated Radiation Therapy, Adaptive Radiotherapy
- Keywords
- Head and Neck Cancer, Oropharyngeal Cancer, Adaptive Radiotherapy, Intensity Modulated Radiation Therapy, IMRT, ART
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
IMRT Treatment Over 6-7 Weeks
Adaptive RadiotherapyRadiation
Also called ART
ART Treatment Over 6-7 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Image-Guided Adaptive Radiotherapy | Experimental | Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART) Receives: Radiation: Intensity Modulated Radiation Therapy; Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning
Comparison of mean dose in the Contralateral Parotid Gland and Ipsilateral Parotid Gland change between one adaptive replan (ART1) and two adaptive replans (ART2) planning relative to standard intensity-modulated radiation therapy (IMRT) planning. Dosimetric comparisons was performed using paired t-testing between plans, with patients serving as their own controls. The median trigger point for ART1 was the 16th treatment fraction. For ART2 patients, the median trigger points for the first and second replanning were the 11th and the 22nd fractions, respectively. Percent change in mean dose calculated for each group as 100% (mean post baseline (ART1 or ART2) dosage minus mean baseline IMRT dose for each parotid gland
Measured: Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment
Secondary outcomes (1)
Number of Participants With Overall Shrinkage of Tumor With Adaptive Radiotherapy (ART)
Measure parotid volumes shrinkage for the first adaptive radiotherapy (ART1) replanning for the number of participants at the median trigger point of 16th treatment fraction.
Measured: Baseline by IMRT plan and adaptive dosing by ART plan evaluated at the end of the 6-7 week course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adam Garden, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490282
- Sponsor's protocol ID
- 2006-0947
- Other IDs
- NCI-2012-02092
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2007
- Last updated
- 30 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00490282
- Acronym / sponsor ID
- 2006-0947
- Conditions
- Head and Neck Cancer, Oropharyngeal Cancer
- Keywords
- Head and Neck Cancer, Oropharyngeal Cancer, Adaptive Radiotherapy, Intensity Modulated Radiation Therapy, IMRT, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Posted 30 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.
Detailed description
The Study Scans and Tests:
IMRT is a type of 3-dimensional (3-D) radiation therapy that can focus radiation beams directly on the tumor itself. In this study, the IMRT is given using a standard radiation machine (ExaCT™ machine) that has a CT scanner attached to it. This machine is commonly used in patients with head and neck cancer. It gives the same radiation treatment as most of the other machines at M. D. Anderson. However, in addition to giving radiation treatments, it can also perform CT scans while the patient is in the same position on the treatment table, before the radiation therapy is given.
For this study, your standard of care daily CT scans will be used to help researchers adjust participants' radiation therapy, if necessary, on a weekly basis. In particular, the changes in normal tissue that are being studied are any changes in the salivary glands. An additional research related MRI scan will also be performed in this study, but the MRI scan will not be used to adjust participants' therapy. Researchers want to learn if MRI scanning may be able to help doctors in the future to adjust someone's treatment based on changes in a tumor (its features and size) in response to radiation.
Enrollment in the Study:
If you agree to take part in this study, you will receive IMRT according to the standard schedule (over 6 - 7 weeks). You will sign a separate consent form for the IMRT, and the procedure and its risks will be explained to you at that time.
CT Scans:
During this study, you will have a standard of care CT scan right before each IMRT treatment (over a 6-7 week period of time, depending on the exact schedule your doctor decides would be best for your treatment). These CT scans are standard of care, are used to make sure your treatment is being aimed properly, and would be performed whether you are participating on this trial or not. Once you are set up on the treatment table and are ready for radiation therapy, the table will be turned around and the CT scan will be performed. After the CT scan, which should take about 5-8 minutes, the table will be turned back around to the original position and the radiation treatment will be given to you. In total, about 30-33 CT scans will be performed for this study, depending on the exact number of treatments the doctor decides would be best for your therapy.
Routine MRI Scans:
Routine MRI scans of your head and neck will be performed before treatment (at Week 1) and after treatment (sometime during Weeks 12-14). These scans may be used for routine treatment planning and checking the status of the disease.
Study-Related MRI Scan:
An additional MRI scan will be done halfway through treatment (during Week 3). This MRI scan will be used to help researchers see if MRI scanning may be able to help doctors in the future to adjust someone's treatment based on changes in a tumor (its features and size) in response to radiation. In 15 participants, a repeat baseline study-related MRI scan will be done 48 hours to 1 week following the first routine MRI scan.
Modified Barium Swallow:
Your swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make your throat more visible in the x-rays. A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat.
MBS will be performed before you start radiation therapy, 4-6 months after the end of radiation therapy, and during your routine follow-up visits, 12 months (plus or minus 2 months), and 24 months (plus or minus 3 months).
Saliva Testing:
One reason IMRT is being used is to try to protect your parotid glands (the largest of the salivary glands) from receiving too much radiation. To check this, a study-related saliva test will be done. For this test, the amount of saliva your parotid glands create will be measured before treatment (within 7 days before Week 1) and at the last week of treatment (during Week 6 or 7). Do not eat or drink anything, or put anything in your mouth, for 1 hour before the saliva collections. You will be asked to let your saliva collect in your mouth for 5 minutes and then spit into a cup. After that, you will be given a mild citric acid solution (like lemon juice) to put in your mouth. You will let the saliva collect in your mouth for 5 minutes and then spit in a cup. Saliva testing will be performed under a separate protocol (LAB07-0050).
Length of Study:
If the disease gets worse or intolerable side effects occur, you will be taken off this study.
Follow-Up Visits:
At some time between Weeks 22 and 24, then every 3-4 months for up to 2 years after the last IMRT, you will return for follow-up visits. The amount of saliva your parotid glands create will be measured 6 weeks after radiation therapy, 4-6 months after radiation therapy, 1 year (plus or minus 2 months) after radiation therapy, and 2 years (plus or minus 3 months) after radiation therapy.
This is an investigational study. The ExaCT™ machine is FDA approved for use in IMRT in patients with head and neck cancer. Researchers are using this standard of care CT Scan for routine quality assurance to make sure your treatment is given correctly. Up to 45 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Adaptive Radiotherapy | Experimental | Radiation: Intensity Modulated Radiation Therapy, Radiation: Adaptive RadiotherapyIntensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.
- Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (7 listed)
- Patients who have undergone definitive resection of the primary tumor.
- Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
- Prior radiation therapy to the head and neck region.
- Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
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 |
|---|---|---|
| Intensity Modulated Radiation TherapyAlso: IMRTIMRT Treatment Over 6-7 Weeks | Radiation | Image-Guided Adaptive Radiotherapy |
| Adaptive RadiotherapyAlso: ARTART Treatment Over 6-7 Weeks | Radiation | Image-Guided Adaptive Radiotherapy |
Primary outcome
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning
Time frame: Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment
Comparison of mean dose in the Contralateral Parotid Gland and Ipsilateral Parotid Gland change between one adaptive replan (ART1) and two adaptive replans (ART2) planning relative to standard intensity-modulated radiation therapy (IMRT) planning. Dosimetric comparisons was performed using paired t-testing between plans, with patients serving as their own controls. The median trigger point for ART1 was the 16th treatment fraction. For ART2 patients, the median trigger points for the first and second replanning were the 11th and the 22nd fractions, respectively. Percent change in mean dose calculated for each group as 100% (mean post baseline (ART1 or ART2) dosage minus mean baseline IMRT dose for each parotid gland
1 secondary outcome
Number of Participants With Overall Shrinkage of Tumor With Adaptive Radiotherapy (ART)
Time frame: Baseline by IMRT plan and adaptive dosing by ART plan evaluated at the end of the 6-7 week course of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Adam Garden, MD principal investigator
M.D. Anderson Cancer 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 Intensity Modulated Radiation Therapy and Adaptive Radiotherapy in people with Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer 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 3 inclusion and 7 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 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning (time frame: Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment). 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 Dec 2020.