Trial Outcomes & Findings for Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT00526890)
NCT ID: NCT00526890
Last Updated: 2017-11-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
During study treatment, up to 6 weeks
Results posted on
2017-11-28
Participant Flow
Participant milestones
| Measure |
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Age, Continuous
|
63.25 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During study treatment, up to 6 weeksPopulation: Treated with Study Therapy
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Incidence of Grade 3-4 Esophagitis
|
18.75 percentage of participants
Interval 4.05 to 45.65
|
PRIMARY outcome
Timeframe: During study treatment, up to 6 weeksPopulation: Patients treated with study therapy
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Incidence of Grade 3-4 Pneumonitis
|
0 percentage of participants
Interval 0.0 to 20.59
|
PRIMARY outcome
Timeframe: During study treatment, up to 6 weeksPopulation: Patients Treated with Study Therapy
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Incidence of Grade 3-4 Myelosuppression
|
12.50 percentage of participants
Interval 1.55 to 38.35
|
SECONDARY outcome
Timeframe: 1 month post-treatment, then q 3 months x 4Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Response Rate
|
50 percentage of patients
Interval 24.65 to 75.35
|
SECONDARY outcome
Timeframe: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.Population: Patients treated with study therapy
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Failure-free Survival
|
9.0 months
Interval 3.3 to 21.5
|
SECONDARY outcome
Timeframe: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafterPopulation: Patients treated with study therapy
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Overall Survival
|
14.5 months
Interval 7.5 to
NA (not available): the upper bound of the 95% CI was not reached but is \>36.4 months
|
SECONDARY outcome
Timeframe: Pre-treatment and every week for 6 weeks prior to chemotherapy.Population: All treated and eligible patients
Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Outcome measures
| Measure |
CPSR
n=16 Participants
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Selenium Level by Incidence of SAE
No SAE
|
1435.0 ng/mL
Interval 847.9 to 2870.3
|
|
Selenium Level by Incidence of SAE
SAE
|
1803.6 ng/mL
Interval 1465.0 to 2039.5
|
Adverse Events
CPSR
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPSR
n=16 participants at risk
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Cardiac disorders
Atrial fibrillation - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Urinary tract infection - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 4
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
CPSR
n=16 participants at risk
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
43.8%
7/16 • Number of events 9
|
|
Blood and lymphatic system disorders
Anaemia - Grade 2
|
25.0%
4/16 • Number of events 5
|
|
Blood and lymphatic system disorders
Anaemia - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 1
|
50.0%
8/16 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
37.5%
6/16 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 1
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Cardiac disorders
Arrhythmia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Tachycardia - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Breath odour - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Chapped lips - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
31.2%
5/16 • Number of events 6
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal pain - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 1
|
31.2%
5/16 • Number of events 6
|
|
Gastrointestinal disorders
Oesophagitis - Grade 2
|
56.2%
9/16 • Number of events 10
|
|
Gastrointestinal disorders
Oesophagitis - Grade 3
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Chest pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue - Grade 1
|
37.5%
6/16 • Number of events 7
|
|
General disorders
Fatigue - Grade 2
|
18.8%
3/16 • Number of events 4
|
|
General disorders
Fatigue - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Mucosal inflammation - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pain - Grade 2
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Pyrexia - Grade 1
|
6.2%
1/16 • Number of events 3
|
|
Infections and infestations
Bacterial infection - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Herpes zoster - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Urinary tract infection - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Urinary tract infection - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis - Grade 2
|
18.8%
3/16 • Number of events 3
|
|
Injury, poisoning and procedural complications
Radiation skin injury - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Weight decreased - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Weight decreased - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 1
|
43.8%
7/16 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 2
|
31.2%
5/16 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 3
|
37.5%
6/16 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 1
|
25.0%
4/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 1
|
25.0%
4/16 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dizziness - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Headache - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Insomnia - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
12.5%
2/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats - Grade 1
|
12.5%
2/16 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis - Grade 3
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 1
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 2
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 3
|
6.2%
1/16 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place