NCT01586182

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

April 24, 2012

Last Update Submit

September 2, 2015

Conditions

Squamous Cell Carcinoma of the Oropharynx

Keywords

poor prognosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Safety and Tolerability of Stereotactic Boost

    2 years

  • Overall Survival

    2 years

  • Disease-Free Survival

    2 years

Study Arms (1)

Stereotactic Boost

EXPERIMENTAL

Escalating doses of stereotactic body radiation therapy (SBRT)

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body RadiotherapyRADIATION

Starting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease

Stereotactic Boost

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 26, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

September 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

US(2)