Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma

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.

Study Overview

• Status: Withdrawn
• Conditions: Squamous Cell Carcinoma of the Oropharynx
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of MTD	Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma	2 years
Two Year Local Control Rate	Local failure is defined as biopsy-proven recurrent disease	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
Overall Survival	To determine the 2 year overall survivial	2 years
Disease-Free Survival	To determine the 2-year disease-free survival	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: poor prognosis
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 11-037