NCT00851253

Brief Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

December 1, 2017

Enrollment Period

5.9 years

First QC Date

February 24, 2009

Results QC Date

July 10, 2017

Last Update Submit

December 17, 2017

Conditions

Head and Neck Cancer

Keywords

recurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage II basal cell carcinoma of the lipstage III basal cell carcinoma of the liprecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxhigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage II salivary gland cancerstage III salivary gland cancerstage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV verrucous carcinoma of the oral cavitystage IV salivary gland cancerstage IV lymphoepithelioma of the nasopharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV basal cell carcinoma of the lip

Outcome Measures

Primary Outcomes (1)

  • Duration of Local Control

    Median time to local failure based on regional or distant metastatic disease

    1 year

Secondary Outcomes (1)

  • Rates of Adverse Events Associated With Treatment

    1 year

Study Arms (2)

Group 1 (CK SRS boost therapy)

EXPERIMENTAL

Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.

Radiation: stereotactic radiosurgery

Group 2 (CK SRS salvage therapy)

EXPERIMENTAL

Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.

Radiation: stereotactic radiosurgery

Interventions

stereotactic radiosurgeryRADIATION

Given in 2 fractionated doses or 5 fractionated doses

Also known as: CyberKnife
Group 1 (CK SRS boost therapy)Group 2 (CK SRS salvage therapy)

Eligibility Criteria

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

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Biopsy-confirmed\* invasive head and neck cancer, including the following primary sites:
  • Nasopharynx
  • Oropharynx
  • Paranasal sinus
  • Oral cavity
  • Orbit
  • Salivary gland NOTE: \*Biopsy must be performed prior to initiation of external beam radiotherapy (EBRT)
  • Stage T2-4 tumor at the time of diagnosis
  • Primary tumor ≤ 5 cm in diameter at the time of CyberKnife® stereotactic radiosurgery (SRS)
  • Meets one of the following criteria:
  • Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following criteria:
  • Planning to undergo definitive EBRT, with or without chemotherapy, with curative intent for primary head and neck cancer
  • Biopsy-confirmed locally persistent disease \< 3 months after completion of definitive EBRT
  • Eligible for CyberKnife® SRS as salvage therapy\*, as defined by one of the following criteria:
  • +11 more criteria

You may not qualify if:

  • No laryngeal or hypopharyngeal cancer
  • No evidence of distant metastases
  • No prior brachytherapy
  • No prior CyberKnife® SRS boost or salvage therapy
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No active connective tissue disorders (e.g., lupus or scleroderma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Dr. Minh Tam Truong
Organization
Boston Medical Center
Minh-Tam.Truong@bmc.org
617-638-7070

Study Officials

  • Minh T. Truong, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2014

Study Completion

April 1, 2017

Last Updated

January 17, 2018

Results First Posted

January 17, 2018

Record last verified: 2017-12

Locations

US(1)