Squamous Cell Carcinoma of the OropharynxPhase 1/2NCT01586182
Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma
A Phase 1/2 study testing Stereotactic Body Radiotherapy in people with Squamous Cell Carcinoma of the Oropharynx, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention (in this case, the stereotactic radiation boost). Phase I studies also try to define the appropriate dose of the investigational intervention to use for further studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Sep 2015
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated histologically or cytologically confirmed T2-4, N0-3 HPV16-negative oropharyngeal squamous cell carcinoma or HPV16 positivity with at least a 10 pack-year smoking habit
- Measurable disease
- Life expectancy of greater than 6 months
Who cannot join
- Other active malignancy within the past 5 years (except for non-melanoma skin cancer or carcinoma in situ of the cervix)
- Primary tumor size > 6 cm
- Prior history of head and neck radiotherapy
- Receiving any other study agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- HIV positive on combination antiretroviral therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention (in this case, the stereotactic radiation boost). Phase I studies also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the stereotactic radiation treatment is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved a stereotactic radiation boost for your type of cancer.
In this research study, the investigators are looking for the highest dose of the stereotactic radiation boost that can be given safely. Because the stereotactic radiation boost is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects you experience; the goal is to improve the likelihood of successfully treating the tumor.
Read the detailed description
After confirming that you are eligible for this study and your willingness to participate in it, we will perform a radiation treatment stimulation, or "mapping session," within the next two weeks. You may or may not receive intravenous contrast during the process, which allows your physician to better see the blood vessels in your neck. You will be placed in a mask during this process to help keep you in the same place during each treatment. All of this is part of standard radiation treatment.
Approximately 14 days later, you will start radiation treatment to your primary tumor site and to your lymph nodes and chemotherapy in the same week. The chemotherapy will continue to be given one time per week during each week of treatment. You will receive radiation treatment 5 days a week for seven weeks. One day each during the first and second weeks of treatment, instead of the typical radiation dose, you will receive a dose of the stereotactic radiation boost to the site of the primary tumor (total of 2 doses of stereotactic radiotherapy).
Because we are looking for the highest dose of the stereotactic radiation boost that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the stereotactic radiation boost. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. We are testing 3 different dose levels for the stereotactic radiation boost; your dose will be one of those 3 doses.
The chemotherapy will be given one time per week, each week, for the duration of the radiation treatment (7 weeks). The chemotherapy is delivered through intravenous fluids that run through a vein in your arm. This is the same chemotherapy that you would receive if you were not participating in the study.
You will be seen by your radiation oncologist at least once every week during treatment.
After the final dose of radiation treatment all subsequent follow-up visits and tests are performed in accordance with standard cancer care. You will see your radiation oncologist, with or without the medical oncologist, at the following time intervals: 1 week after treatment ends, 1 month after treatment ends, 2 months after treatment ends, and then every 3 months for two years. You will undergo a PET-CT scan and neck CT scan at the time of the 3 month appointment.
You will be on the study treatment for about 7 weeks and your progress will be followed as part of the study for 2 years after treatment ends.
- Being tested
- Stereotactic Body Radiotherapy
- Keywords
- poor prognosis
- Medical subject headings
- 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.
Stereotactic Body RadiotherapyRadiation
Starting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Boost | Experimental | Escalating doses of stereotactic body radiation therapy (SBRT) Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTD
Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma
Measured: 2 years
Two Year Local Control Rate
Local failure is defined as biopsy-proven recurrent disease
Measured: 2 years
Secondary outcomes (3)
Safety and Tolerability of Stereotactic Boost
To evaluate the safety and tolerability of a stereotactic boost to chemoradiotherapy, including both acute and long-term toxicity
Measured: 2 years
Overall Survival
To determine the 2 year overall survivial
Measured: 2 years
Disease-Free Survival
To determine the 2-year disease-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionSep 2015
Why it stopped: Local IRB closed the study due to poor accural.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy B. Tishler, MD, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586182
- Sponsor's protocol ID
- 11-037
- Status last verified
- Sep 2015
- First submitted
- 24 Apr 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01586182
- Acronym / sponsor ID
- 11-037
- Keywords
- poor prognosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Local IRB closed the study due to poor accural.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Apr 2012 (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 research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention (in this case, the stereotactic radiation boost). Phase I studies also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the stereotactic radiation treatment is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved a stereotactic radiation boost for your type of cancer.
In this research study, the investigators are looking for the highest dose of the stereotactic radiation boost that can be given safely. Because the stereotactic radiation boost is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects you experience; the goal is to improve the likelihood of successfully treating the tumor.
Detailed description
After confirming that you are eligible for this study and your willingness to participate in it, we will perform a radiation treatment stimulation, or "mapping session," within the next two weeks. You may or may not receive intravenous contrast during the process, which allows your physician to better see the blood vessels in your neck. You will be placed in a mask during this process to help keep you in the same place during each treatment. All of this is part of standard radiation treatment.
Approximately 14 days later, you will start radiation treatment to your primary tumor site and to your lymph nodes and chemotherapy in the same week. The chemotherapy will continue to be given one time per week during each week of treatment. You will receive radiation treatment 5 days a week for seven weeks. One day each during the first and second weeks of treatment, instead of the typical radiation dose, you will receive a dose of the stereotactic radiation boost to the site of the primary tumor (total of 2 doses of stereotactic radiotherapy).
Because we are looking for the highest dose of the stereotactic radiation boost that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the stereotactic radiation boost. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. We are testing 3 different dose levels for the stereotactic radiation boost; your dose will be one of those 3 doses.
The chemotherapy will be given one time per week, each week, for the duration of the radiation treatment (7 weeks). The chemotherapy is delivered through intravenous fluids that run through a vein in your arm. This is the same chemotherapy that you would receive if you were not participating in the study.
You will be seen by your radiation oncologist at least once every week during treatment.
After the final dose of radiation treatment all subsequent follow-up visits and tests are performed in accordance with standard cancer care. You will see your radiation oncologist, with or without the medical oncologist, at the following time intervals: 1 week after treatment ends, 1 month after treatment ends, 2 months after treatment ends, and then every 3 months for two years. You will undergo a PET-CT scan and neck CT scan at the time of the 3 month appointment.
You will be on the study treatment for about 7 weeks and your progress will be followed as part of the study for 2 years after treatment ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Boost | Experimental | Radiation: Stereotactic Body RadiotherapyEscalating doses of stereotactic body radiation therapy (SBRT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously untreated histologically or cytologically confirmed T2-4, N0-3 HPV16-negative oropharyngeal squamous cell carcinoma or HPV16 positivity with at least a 10 pack-year smoking habit
- Measurable disease
- Life expectancy of greater than 6 months
Key exclusion criteria (8 listed)
- Other active malignancy within the past 5 years (except for non-melanoma skin cancer or carcinoma in situ of the cervix)
- Primary tumor size > 6 cm
- Prior history of head and neck radiotherapy
- Receiving any other study agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin
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 |
|---|---|---|
| Stereotactic Body RadiotherapyStarting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease | Radiation | Stereotactic Boost |
Primary outcome
Determination of MTD
Time frame: 2 years
Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma
Two Year Local Control Rate
Time frame: 2 years
Local failure is defined as biopsy-proven recurrent disease
3 secondary outcomes
Safety and Tolerability of Stereotactic Boost
Time frame: 2 years
Overall Survival
Time frame: 2 years
Disease-Free Survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Body Radiotherapy in people with Squamous Cell Carcinoma of the Oropharynx, run by Dana-Farber Cancer Institute at 2 sites 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 8 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: withdrawn, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determination of MTD (time frame: 2 years). The study lists 2 primary outcomes in all. 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 4 Sep 2015.