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Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01586182
Recruitment Status : Withdrawn (Local IRB closed the study due to poor accural.)
First Posted : April 26, 2012
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Roy B. Tishler, MD, Dana-Farber Cancer Institute

Study Description
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Brief 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. "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.


Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Oropharynx Radiation: Stereotactic Body Radiotherapy Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Stereotactic Boost
Escalating doses of stereotactic body radiation therapy (SBRT)
 Radiation: Stereotactic Body Radiotherapy
Starting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Two Year Local Control Rate [ Time Frame: 2 years ]
    Local failure is defined as biopsy-proven recurrent disease


Secondary Outcome Measures :
  1. Safety and Tolerability of Stereotactic Boost [ Time Frame: 2 years ]
    To evaluate the safety and tolerability of a stereotactic boost to chemoradiotherapy, including both acute and long-term toxicity

  2. Overall Survival [ Time Frame: 2 years ]
    To determine the 2 year overall survivial

  3. Disease-Free Survival [ Time Frame: 2 years ]
    To determine the 2-year disease-free survival


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586182


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
More Information
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Responsible Party: Roy B. Tishler, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01586182    
Other Study ID Numbers: 11-037
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Keywords provided by Roy B. Tishler, MD, Dana-Farber Cancer Institute:
poor prognosis
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site