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Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00851253
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Minh Tam Truong, Boston Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Radiation: stereotactic radiosurgery
Enrollment 12
Recruitment Details Participants were recruited from within the investigators clinic practice between February 2009 and August 2013
Pre-assignment Details One subject that was enrolled onto the Boost Arm was withdrawn prior to undergoing cyberknife therapy due to disease progression.
Arm/Group Title Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Hide Arm/Group Description

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

Period Title: Overall Study
Started 2 10
Completed 1 10
Not Completed 1 0
Reason Not Completed
Disease Progression             1             0
Arm/Group Title Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy) Total
Hide Arm/Group Description

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

Total of all reporting groups
Overall Number of Baseline Participants 2 10 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 10 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
5
  50.0%
5
  41.7%
>=65 years
2
 100.0%
5
  50.0%
7
  58.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 10 participants 12 participants
Female
0
   0.0%
7
  70.0%
7
  58.3%
Male
2
 100.0%
3
  30.0%
5
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 10 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  10.0%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
 100.0%
2
  20.0%
4
  33.3%
White
0
   0.0%
6
  60.0%
6
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  10.0%
1
   8.3%
1.Primary Outcome
Title Duration of Local Control
Hide Description Median time to local failure based on regional or distant metastatic disease
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Boost subjects were not evaluable.
Arm/Group Title Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Hide Arm/Group Description:

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

Overall Number of Participants Analyzed 0 10
Median (Standard Deviation)
Unit of Measure: number of months to local failure
4.6  (1.6)
2.Secondary Outcome
Title Rates of Adverse Events Associated With Treatment
Hide Description Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.
Arm/Group Title Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Hide Arm/Group Description:

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

Overall Number of Participants Analyzed 1 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Hide Arm/Group Description

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

All-Cause Mortality
Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      1/10 (10.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      9/10 (90.00%)    
Blood and lymphatic system disorders     
hemorrhage  1  0/1 (0.00%)  0 3/10 (30.00%)  3
neutropenia  1  0/1 (0.00%)  0 1/10 (10.00%)  1
hemoglobinemia  1  0/1 (0.00%)  0 1/10 (10.00%)  1
Ear and labyrinth disorders     
osteomyelitis  1  0/1 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders     
dehydration  1  1/1 (100.00%)  1 1/10 (10.00%)  1
dysphagia  1  0/1 (0.00%)  0 2/10 (20.00%)  2
General disorders     
pain  1  1/1 (100.00%)  1 2/10 (20.00%)  2
ulceration  1  0/1 (0.00%)  0 1/10 (10.00%)  1
fatigue  1  0/1 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Trismus  1  1/1 (100.00%)  1 1/10 (10.00%)  1
osteonecrosis  1  0/1 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
dyspnea  1  0/1 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 (CK SRS Boost Therapy) Group 2 (CK SRS Salvage Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
lypmphatics disorder - other  1 [1]  0/1 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders     
anorexia  1  1/1 (100.00%)  1 0/10 (0.00%)  0
constipation  1  1/1 (100.00%)  1 2/10 (20.00%)  3
dysphagia  1  1/1 (100.00%)  1 1/10 (10.00%)  1
gait disturbance  1  1/1 (100.00%)  1 0/10 (0.00%)  0
nausea  1  0/1 (0.00%)  0 1/10 (10.00%)  1
taste alteration  1  0/1 (0.00%)  0 2/10 (20.00%)  2
mucositis  1  0/1 (0.00%)  0 2/10 (20.00%)  2
dry mouth  1  0/1 (0.00%)  0 2/10 (20.00%)  2
General disorders     
pain  1  0/1 (0.00%)  0 4/10 (40.00%)  4
edema - head and neck  1  1/1 (100.00%)  1 3/10 (30.00%)  3
fatigue  1  1/1 (100.00%)  1 2/10 (20.00%)  2
Investigations     
weight loss  1  0/1 (0.00%)  0 3/10 (30.00%)  3
Musculoskeletal and connective tissue disorders     
muscle weakness  1  1/1 (100.00%)  1 0/10 (0.00%)  0
Nervous system disorders     
dizziness  1  1/1 (100.00%)  1 1/10 (10.00%)  1
neurology - other  1 [2]  0/1 (0.00%)  0 1/10 (10.00%)  2
Psychiatric disorders     
insomnia  1  1/1 (100.00%)  1 2/10 (20.00%)  2
Respiratory, thoracic and mediastinal disorders     
voice alteration  1  0/1 (0.00%)  0 2/10 (20.00%)  2
cough  1  0/1 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
dermatitis  1  0/1 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
moderate secretions from tracheotomy
[2]
headaches 6/10 at worst controlled with pain medication
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Minh Tam Truong
Organization: Boston Medical Center
Phone: 617-638-7070
EMail: Minh-Tam.Truong@bmc.org
Layout table for additonal information
Responsible Party: Minh Tam Truong, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00851253     History of Changes
Other Study ID Numbers: H-26649
W912SQ7058N601 ( Other Grant/Funding Number: Dept of Defense )
First Submitted: February 24, 2009
First Posted: February 25, 2009
Results First Submitted: July 10, 2017
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018