Trial Outcomes & Findings for High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer (NCT NCT00052429)
NCT ID: NCT00052429
Last Updated: 2018-01-09
Results Overview
Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
up to 77 months
Results posted on
2018-01-09
Participant Flow
Participant milestones
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
Baseline characteristics by cohort
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
n=25 Participants
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 77 monthsPatients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.
Outcome measures
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
n=25 Participants
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Survival Rate of Patients
|
33 months
Interval 14.0 to 77.0
|
PRIMARY outcome
Timeframe: every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.
Outcome measures
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
n=25 Participants
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Local Control of Participants
Actuarial rate of local control
|
91 percentage of participants
|
|
Local Control of Participants
Regional control
|
91 percentage of participants
|
|
Local Control of Participants
Metastases-free survival
|
91 percentage of participants
|
|
Local Control of Participants
Overall survival
|
89 percentage of participants
|
Adverse Events
High-Dose Radiation Therapy Plus Chemotherapy
Serious events: 19 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
n=25 participants at risk
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Nervous system disorders
Central nervous system necrosis
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Creatinine increased
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
28.0%
7/25 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
2/25 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25 • Number of events 4
|
|
General disorders
Fever
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hematoma
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hypotension
|
12.0%
3/25 • Number of events 4
|
|
Infections and infestations
Infectious meningitis
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis-Oral cavity
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
3/25 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Platelet count decrease
|
4.0%
1/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Chills
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • Number of events 2
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • Number of events 2
|
|
Renal and urinary disorders
Renal and urinary disorders -Other, specify-Renal tubular disorder
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Vasovagal reaction
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25 • Number of events 8
|
Other adverse events
| Measure |
High-Dose Radiation Therapy Plus Chemotherapy
n=25 participants at risk
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
|
|---|---|
|
Ear and labyrinth disorders
Ear disorder
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Fatigue
|
16.0%
4/25 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis-Oral
|
8.0%
2/25 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
16.0%
4/25 • Number of events 4
|
|
Ear and labyrinth disorders
Tinnitus
|
24.0%
6/25 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2
|
Additional Information
Dr. Suzanne Wolden
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5148
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place