Trial Outcomes & Findings for Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer (NCT NCT00274937)
NCT ID: NCT00274937
Last Updated: 2022-10-25
Results Overview
The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Up to Two Year After Enrollment
Results posted on
2022-10-25
Participant Flow
No patients were enrolled to Stratum 1.
Participant milestones
| Measure |
Stratum II
AJCC Stage IIb - IV
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Stratum II
AJCC Stage IIb - IV
|
|---|---|
|
Overall Study
Physician Decision
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Progressive Disease
|
4
|
Baseline Characteristics
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Stratum II
n=111 Participants
AJCC Stage IIb - IV
|
|---|---|
|
Age, Continuous
|
13.8 Participants
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Two Year After EnrollmentPopulation: No patients were enrolled to Stratum 1.
The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.
Outcome measures
| Measure |
Stratum II
n=111 Participants
AJCC Stage IIb - IV
|
|---|---|
|
Two Year Event-free Survival (EFS)
|
0.87 Estimated probability
Interval 0.79 to 0.92
|
SECONDARY outcome
Timeframe: At study enrollmentPopulation: Data was and never will be collected.
Presence of EBV DNA in serum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At study enrollmentPopulation: Data was and never will be collected.
Viral load in blood.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Funding was not obtained and results will never be reported.
The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At study enrollmentPopulation: Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production. This outcome measure was only collected for patients in Stratum 2.
Weight of stimulated saliva production in grams.
Outcome measures
| Measure |
Stratum II
n=26 Participants
AJCC Stage IIb - IV
|
|---|---|
|
Protective Effects of Amifostine Assessed Primarily by Sialometry
At study Enrollment
|
4.97 Grams of saliva
Standard Deviation 5.44
|
|
Protective Effects of Amifostine Assessed Primarily by Sialometry
At end of consolidation
|
3.39 Grams of saliva
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: At study enrollmentPopulation: Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production. This outcome measure was only collected for patients in Stratum 2.
Weight of unstimulated saliva production in grams.
Outcome measures
| Measure |
Stratum II
n=29 Participants
AJCC Stage IIb - IV
|
|---|---|
|
Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
At study Enrollment
|
3.37 Grams of saliva
Standard Deviation 4.49
|
|
Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
At end of consolidation
|
2.30 Grams of saliva
Standard Deviation 3.90
|
Adverse Events
Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)
Serious events: 79 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)
n=111 participants at risk
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.
amifostine trihydrate: Given subcutaneously
fluorouracil: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies
radiation therapy: Undergo radiotherapy
|
|---|---|
|
Infections and infestations
Abdominal infection
|
2.7%
3/111
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/111
|
|
Metabolism and nutrition disorders
Acidosis
|
0.90%
1/111
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.90%
1/111
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
4/111
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
2/111
|
|
Immune system disorders
Allergic reaction
|
0.90%
1/111
|
|
Blood and lymphatic system disorders
Anemia
|
8.1%
9/111
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
19/111
|
|
Psychiatric disorders
Anxiety
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.90%
1/111
|
|
Investigations
Aspartate aminotransferase increased
|
0.90%
1/111
|
|
Investigations
Blood bilirubin increased
|
1.8%
2/111
|
|
Investigations
Cardiac troponin I increased
|
0.90%
1/111
|
|
Infections and infestations
Catheter related infection
|
1.8%
2/111
|
|
Gastrointestinal disorders
Cheilitis
|
0.90%
1/111
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.8%
2/111
|
|
Gastrointestinal disorders
Constipation
|
3.6%
4/111
|
|
Metabolism and nutrition disorders
Dehydration
|
13.5%
15/111
|
|
Psychiatric disorders
Depression
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.90%
1/111
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
7/111
|
|
Gastrointestinal disorders
Dysphagia
|
9.9%
11/111
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.90%
1/111
|
|
General disorders
Edema face
|
0.90%
1/111
|
|
Investigations
Ejection fraction decreased
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.8%
2/111
|
|
Gastrointestinal disorders
Esophageal pain
|
1.8%
2/111
|
|
Gastrointestinal disorders
Esophagitis
|
3.6%
4/111
|
|
Infections and infestations
Eye infection
|
0.90%
1/111
|
|
General disorders
Fatigue
|
4.5%
5/111
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.90%
1/111
|
|
General disorders
Fever
|
0.90%
1/111
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
2/111
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.90%
1/111
|
|
Nervous system disorders
Headache
|
1.8%
2/111
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.2%
18/111
|
|
Cardiac disorders
Heart failure
|
0.90%
1/111
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.8%
2/111
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.1%
9/111
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.5%
5/111
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.90%
1/111
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.8%
2/111
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.3%
7/111
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.6%
14/111
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.1%
9/111
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.0%
10/111
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.0%
10/111
|
|
Vascular disorders
Hypotension
|
2.7%
3/111
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.5%
5/111
|
|
Investigations
Investigations - Other, specify
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.90%
1/111
|
|
Infections and infestations
Lip infection
|
0.90%
1/111
|
|
Investigations
Lymphocyte count decreased
|
10.8%
12/111
|
|
Gastrointestinal disorders
Mucositis oral
|
24.3%
27/111
|
|
Gastrointestinal disorders
Nausea
|
22.5%
25/111
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
2/111
|
|
Investigations
Neutrophil count decreased
|
24.3%
27/111
|
|
General disorders
Non-cardiac chest pain
|
0.90%
1/111
|
|
Gastrointestinal disorders
Oral pain
|
8.1%
9/111
|
|
General disorders
Pain
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.90%
1/111
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
4.5%
5/111
|
|
Infections and infestations
Pharyngitis
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.5%
5/111
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.90%
1/111
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.90%
1/111
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.90%
1/111
|
|
Nervous system disorders
Seizure
|
2.7%
3/111
|
|
Infections and infestations
Sepsis
|
0.90%
1/111
|
|
Cardiac disorders
Sinus tachycardia
|
0.90%
1/111
|
|
Infections and infestations
Sinusitis
|
0.90%
1/111
|
|
Infections and infestations
Skin infection
|
0.90%
1/111
|
|
Infections and infestations
Small intestine infection
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.8%
2/111
|
|
Gastrointestinal disorders
Stomach pain
|
0.90%
1/111
|
|
Nervous system disorders
Syncope
|
1.8%
2/111
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.8%
2/111
|
|
Infections and infestations
Vaginal infection
|
0.90%
1/111
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
2/111
|
|
Cardiac disorders
Ventricular fibrillation
|
0.90%
1/111
|
|
Cardiac disorders
Ventricular tachycardia
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.90%
1/111
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
21/111
|
|
Investigations
Weight loss
|
7.2%
8/111
|
|
Investigations
White blood cell decreased
|
18.0%
20/111
|
Other adverse events
| Measure |
Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)
n=111 participants at risk
Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.
amifostine trihydrate: Given subcutaneously
fluorouracil: Given IV
cisplatin: Given IV
laboratory biomarker analysis: Correlative studies
radiation therapy: Undergo radiotherapy
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
0.90%
1/111
|
|
Gastrointestinal disorders
Diarrhea
|
0.90%
1/111
|
|
Nervous system disorders
Dizziness
|
0.90%
1/111
|
|
Nervous system disorders
Dysgeusia
|
0.90%
1/111
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.90%
1/111
|
|
Ear and labyrinth disorders
Ear pain
|
0.90%
1/111
|
|
Gastrointestinal disorders
Esophageal pain
|
0.90%
1/111
|
|
General disorders
Fever
|
2.7%
3/111
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.90%
1/111
|
|
Nervous system disorders
Headache
|
0.90%
1/111
|
|
Ear and labyrinth disorders
Hearing impaired
|
26.1%
29/111
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.90%
1/111
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.90%
1/111
|
|
Psychiatric disorders
Insomnia
|
0.90%
1/111
|
|
Gastrointestinal disorders
Nausea
|
0.90%
1/111
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.90%
1/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.90%
1/111
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.90%
1/111
|
|
Cardiac disorders
Sinus bradycardia
|
0.90%
1/111
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.90%
1/111
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
2/111
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/111
|
|
Investigations
Weight loss
|
0.90%
1/111
|
|
Investigations
White blood cell decreased
|
1.8%
2/111
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER