Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
This study is currently recruiting participants.
Verified November 2012 by Boston Medical Center
Sponsor:
Boston Medical Center
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00851253
First received: February 24, 2009
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Radiation: stereotactic radiosurgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer |
Resource links provided by NLM:
Further study details as provided by Boston Medical Center:
Primary Outcome Measures:
- Proportion of patients maintaining local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Rates of adverse events associated with treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 (CyberKnife® SRS boost therapy)
Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
|
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
|
|
Experimental: Group 2 (CyberKnife® SRS salvage therapy)
Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly.
|
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
|
Detailed Description:
OBJECTIVES:
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as boost therapy after standard chemoradiotherapy in patients with locally advanced head and neck cancer.
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as salvage therapy in patients with locally recurrent head and neck cancer.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after prior standard therapy. Patients with residual disease after standard therapy are assigned to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to group 2.
All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning CyberKnife® stereotactic radiosurgery (SRS) treatment.
- Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
- Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly.
After completion of study treatment, patients are followed periodically for up to 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Biopsy-confirmed locally recurrent disease occurring ≥ 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had > 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy
- Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had < 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy NOTE: *Not a candidate for salvage surgery or brachytherapy
- Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior dose)
- No laryngeal or hypopharyngeal cancer
- No evidence of distant metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to achieve normal tissue tolerance to critical structures with the CyberKnife® planning system
- Able to undergo CT simulation
- 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)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior brachytherapy
- No prior CyberKnife® SRS boost or salvage therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851253
Locations
| United States, Massachusetts | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265 | |
Sponsors and Collaborators
Boston Medical Center
Investigators
| Principal Investigator: | Minh T. Truong, MD | Boston University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00851253 History of Changes |
| Other Study ID Numbers: | CDR0000635094, BUMC-H-26649 |
| Study First Received: | February 24, 2009 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Medical Center:
|
salivary gland acinic cell tumor recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage II mucoepidermoid carcinoma of the oral cavity stage II verrucous carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent squamous cell carcinoma of the lip and oral cavity stage II basal cell carcinoma of the lip |
stage III basal cell carcinoma of the lip recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage II lymphoepithelioma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III lymphoepithelioma of the oropharynx stage III squamous cell carcinoma of the oropharynx recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013