Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Squamous Cell Carcinoma of the Oropharynx

In brief

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.

Key facts

Study ID

NCT01586182

Run by

Dana-Farber Cancer Institute

People needed

0

Starts

2011-11-01

Expected to finish

2015-09-01

Last updated by the study team

2015-09-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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