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Trial record 57 of 1973 for:    oxaliplatin

Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00256308
Recruitment Status : Terminated (Halted prematurely due to slow accrual)
First Posted : November 21, 2005
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Sai-Hong Ignatius Ou, University of California, Irvine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Drug: Oxaliplatin
Procedure: Radiation
Enrollment 6
Recruitment Details Study start date: February 2005 Primary completion date: May 2010 Study completion date: October 2011
Pre-assignment Details  
Arm/Group Title Oxaliplatin
Hide Arm/Group Description Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title Oxaliplatin
Hide Arm/Group Description Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  83.3%
>=65 years
1
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
1
  16.7%
Not Hispanic or Latino
2
  33.3%
Unknown or Not Reported
3
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 0
Caucasian 6
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Frequency and Severity of Toxicities
Hide Description Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Although data were collected, events were not analyzed at the time of collection for relatedness to treatment and this analysis cannot be performed retrospectively due to lack of access to complete patient records.
Arm/Group Title Oxaliplatin
Hide Arm/Group Description:
Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Locoregional Control Rate
Hide Description Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated by funding source for slow accrual. Upon termination notification, all research procedures stopped, inclusive of completing any analysis of data collected. Specific information about collection of data could not be located.
Arm/Group Title Oxaliplatin
Hide Arm/Group Description:
Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Disease-free Survival Rate
Hide Description

Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.

Progression-free survival: from date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration

Progression: Appearance of any new lesion/site. The site of the new lesion will be recorded. Death due to disease without prior documentation of progression and without symptomatic deterioration Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants completed survival follow-up. 1 patient had progressive disease and stopped study drug, discovered during follow-up that patient had expired in hospice care. 1 patient completed study treatment but expired in follow up due to staph infection and complications from disease in hospice care.
Arm/Group Title Oxaliplatin
Hide Arm/Group Description:
Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Disease Free
4
  66.7%
Progressive Disease
1
  16.7%
Unknown
1
  16.7%
4.Secondary Outcome
Title Overall Survival Rate
Hide Description

Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.

From date of registration to date of death due to any cause

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants completed follow up period. 2 participants expired in the follow up period. 1 due to progressive disease and 1 due to staph infection and secondary cause of death due to disease complications.
Arm/Group Title Oxaliplatin
Hide Arm/Group Description:
Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Alive
4
  66.7%
Deceased
2
  33.3%
5.Secondary Outcome
Title Sites of Relapse
Hide Description Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants completed the study without any signs of disease. Only 1 participant had progressive disease but does not appear to be a relapse. No information provided to indicate whether other expired participant experienced a relapse.
Arm/Group Title Oxaliplatin
Hide Arm/Group Description:
Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
No evidence of Relapse
5
  83.3%
Unknown
1
  16.7%
Time Frame 2 years
Adverse Event Reporting Description Known adverse events were reported; however, this may not be a complete representation of the adverse events collected in the study due to limited access to the data.
 
Arm/Group Title Oxaliplatin
Hide Arm/Group Description Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
All-Cause Mortality
Oxaliplatin
Affected / at Risk (%)
Total   2/6 (33.33%) 
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin
Affected / at Risk (%)
Total   3/6 (50.00%) 
Gastrointestinal disorders   
Mucositis   1/6 (16.67%) 
General disorders   
Dry Mouth  [1]  2/6 (33.33%) 
Pain  [2]  1/6 (16.67%) 
Nausea  [1]  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Dermitis   1/6 (16.67%) 
Indicates events were collected by systematic assessment
[1]
This adverse event is being reported in this section as a grade determination could not be identified in the patient chart.
[2]
Due to exposed bone inside of the mouth. This event is being reported in this section as a grade determination could not be identified in the patient chart.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxaliplatin
Affected / at Risk (%)
Total   4/6 (66.67%) 
Blood and lymphatic system disorders   
Anemia   1/6 (16.67%) 
Hypomagnesemia   1/6 (16.67%) 
Lymphopenia   1/6 (16.67%) 
Cardiac disorders   
Hypertension   1/6 (16.67%) 
Gastrointestinal disorders   
Esophagitis   1/6 (16.67%) 
General disorders   
Fever   1/6 (16.67%) 
Emesis   1/6 (16.67%) 
Fatigue   1/6 (16.67%) 
Pain  [1]  1/6 (16.67%) 
Sensitivity to Cold   1/6 (16.67%) 
Mucositis   1/6 (16.67%) 
Dry Mouth   1/6 (16.67%) 
Weight Loss   1/6 (16.67%) 
Headaches   1/6 (16.67%) 
Immune system disorders   
Alopecia   1/6 (16.67%) 
Nervous system disorders   
Sensory Neuropathy   1/6 (16.67%) 
Peripheral Neuropathy   1/6 (16.67%) 
Renal and urinary disorders   
Elevated Creatinine   1/6 (16.67%) 
Constipation   1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Shortness of breath   1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Red Skin   1/6 (16.67%) 
Erythma   1/6 (16.67%) 
Indicates events were collected by systematic assessment
[1]
located in mouth
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chao Family Comprehensive Cancer Center
Organization: University of California, Irvine
Phone: (877) 827-8839
EMail: UCstudy@uci.edu
Layout table for additonal information
Responsible Party: Sai-Hong Ignatius Ou, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256308     History of Changes
Other Study ID Numbers: UCI 04-40
2004-3999 ( Other Identifier: University of California, Irvine )
First Submitted: November 17, 2005
First Posted: November 21, 2005
Results First Submitted: June 26, 2013
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018