Head and Neck CancerNCT02003482
Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
An observational study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Postop IMRT for head/neck cancer and CT for Radiation Treatment Planning
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2006to 26 Mar 2018
- Phase
- Observational
- 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
Study population: Patients with pathologic stage I-IV cancers of the head and neck (site of tumor origin nasopharynx, parotid, oral cavity, oropharynx, larynx, or hypopharynx,) either following gross total resection and requiring postoperative XRT for high-risk features or undergoing definitive concurrent chemo-radiation.
Who may be able to join
- AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:
- If gross total resection is performed it must be completed within 7 weeks of registration
- Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
- Pretreatment evaluations required for eligibility include:
- History and physical examination within four weeks prior to study entry
- Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation
Show all 12Show fewer
- Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment
- Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required
- Patients must be ≥ 18 years of age.
- Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
- Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in accordance with local regulations, whichever is more sensitive).
- Patients must sign a study-specific informed consent form prior to registration.
Who cannot join
- Histology positive for melanoma.
- Gross (visible or palpable) disease left after surgery.
- Less than gross total resection or patients requiring staged surgery.
- Prior head and neck radiotherapy.
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
Read the detailed description
The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.
- Being tested
- Postop IMRT for head/neck cancer, CT for Radiation Treatment Planning
- Keywords
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Intensity modulated radiation therapy, IMRT, Anatomic Changes, Postoperative, Unresectable
- Medical subject headings
- Head and Neck 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.
Postop IMRT for head/neck cancerRadiation
Also called IMRT
Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.
CT for Radiation Treatment PlanningDevice
Also called CT Simulation
Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Postop IMRT for Head/Neck cancer | CT for Radiation Treatment Planning Receives: Radiation: Postop IMRT for head/neck cancer; Device: CT for Radiation Treatment Planning | |
| Chemo/IMRT for bulky Head/Neck cancer | CT for Radiation Treatment Planning Receives: Radiation: Postop IMRT for head/neck cancer; Device: CT for Radiation Treatment Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.
Measured: 7 weeks
Secondary outcomes (2)
Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer
To determine whether patients undergoing standard IMRT for head and neck cancers require re-planning during the course of therapy, due to volumetric or dosimetric changes.
Measured: 7 weeks
Length of Time Required for Replanning of Radiation Therapy
To estimate what the appropriate time course should be for re-planning of radiation therapy if it is deemed necessary.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study start9 May 2006
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
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.
- More trials run by University of MiamiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Takita, MD, University of Miami
- Investigators
- Cristiane Takita, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003482
- Sponsor's protocol ID
- 20060212
- Status last verified
- Mar 2018
- First submitted
- 2 Dec 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
- ClinicalTrials.gov ID
- NCT02003482
- Acronym / sponsor ID
- 20060212
- Keywords
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Intensity modulated radiation therapy, IMRT, Anatomic Changes, Postoperative, Unresectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 9 May 2006 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 6 Dec 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.
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
Detailed description
The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postop IMRT for Head/Neck cancer | – | Radiation: Postop IMRT for head/neck cancer, Device: CT for Radiation Treatment PlanningCT for Radiation Treatment Planning |
| Chemo/IMRT for bulky Head/Neck cancer | – | Radiation: Postop IMRT for head/neck cancer, Device: CT for Radiation Treatment PlanningCT for Radiation Treatment Planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologic stage I-IV cancers of the head and neck (site of tumor origin nasopharynx, parotid, oral cavity, oropharynx, larynx, or hypopharynx,) either following gross total resection and requiring postoperative XRT for high-risk features or undergoing definitive concurrent chemo-radiation.
Key inclusion criteria (12 listed)
- AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:
- Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
- Pretreatment evaluations required for eligibility include:
- Patients must be ≥ 18 years of age.
- Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
Key exclusion criteria (5 listed)
- Histology positive for melanoma.
- Gross (visible or palpable) disease left after surgery.
- Less than gross total resection or patients requiring staged surgery.
- Prior head and neck radiotherapy.
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
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 |
|---|---|---|
| Postop IMRT for head/neck cancerAlso: IMRTPatients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made. | Radiation | Chemo/IMRT for bulky Head/Neck cancer, Postop IMRT for Head/Neck cancer |
| CT for Radiation Treatment PlanningAlso: CT SimulationTreatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment | Device | Chemo/IMRT for bulky Head/Neck cancer, Postop IMRT for Head/Neck cancer |
Primary outcome
Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
Time frame: 7 weeks
To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.
2 secondary outcomes
Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer
Time frame: 7 weeks
Length of Time Required for Replanning of Radiation Therapy
Time frame: 7 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 29 Mar 2018.
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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.
Cristiane Takita, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Miami 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 12 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 29 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 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?
Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients (time frame: 7 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 29 Mar 2018.