Trial Outcomes & Findings for Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer (NCT NCT00256308)
NCT ID: NCT00256308
Last Updated: 2018-05-01
Results Overview
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.
TERMINATED
PHASE2
6 participants
2 years
2018-05-01
Participant Flow
Study start date: February 2005 Primary completion date: May 2010 Study completion date: October 2011
Participant milestones
| Measure |
Oxaliplatin
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 Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Oxaliplatin
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 Study
Death
|
2
|
Baseline Characteristics
Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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
Outcome measures
| Measure |
Oxaliplatin
n=6 Participants
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.
|
|---|---|
|
Disease-free Survival Rate
Unknown
|
1 Participants
|
|
Disease-free Survival Rate
Disease Free
|
4 Participants
|
|
Disease-free Survival Rate
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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
Outcome measures
| Measure |
Oxaliplatin
n=6 Participants
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 Survival Rate
Alive
|
4 Participants
|
|
Overall Survival Rate
Deceased
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Oxaliplatin
n=6 Participants
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.
|
|---|---|
|
Sites of Relapse
No evidence of Relapse
|
5 Participants
|
|
Sites of Relapse
Unknown
|
1 Participants
|
Adverse Events
Oxaliplatin
Serious adverse events
| Measure |
Oxaliplatin
n=6 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
16.7%
1/6 • 2 years
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.
|
|
Skin and subcutaneous tissue disorders
Dermitis
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Dry Mouth
|
33.3%
2/6 • 2 years
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.
|
|
General disorders
Pain
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Nausea
|
16.7%
1/6 • 2 years
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.
|
Other adverse events
| Measure |
Oxaliplatin
n=6 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Red Skin
|
16.7%
1/6 • 2 years
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.
|
|
Renal and urinary disorders
Elevated Creatinine
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Fever
|
16.7%
1/6 • 2 years
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.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • 2 years
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.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
16.7%
1/6 • 2 years
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.
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • 2 years
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.
|
|
Renal and urinary disorders
Constipation
|
16.7%
1/6 • 2 years
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.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • 2 years
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.
|
|
Immune system disorders
Alopecia
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Emesis
|
16.7%
1/6 • 2 years
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.
|
|
Nervous system disorders
Sensory Neuropathy
|
16.7%
1/6 • 2 years
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.
|
|
Gastrointestinal disorders
Esophagitis
|
16.7%
1/6 • 2 years
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.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Fatigue
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Pain
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Sensitivity to Cold
|
16.7%
1/6 • 2 years
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.
|
|
Nervous system disorders
Peripheral Neuropathy
|
16.7%
1/6 • 2 years
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.
|
|
Skin and subcutaneous tissue disorders
Erythma
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Mucositis
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Dry Mouth
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Weight Loss
|
16.7%
1/6 • 2 years
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.
|
|
General disorders
Headaches
|
16.7%
1/6 • 2 years
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.
|
Additional Information
Chao Family Comprehensive Cancer Center
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place