Trial Outcomes & Findings for Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer (NCT NCT01190527)
NCT ID: NCT01190527
Last Updated: 2017-06-02
Results Overview
Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
2 years
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
Adaptive Radiation
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Adaptive Radiation
n=42 Participants
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
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|---|---|
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Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsUse FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
Outcome measures
| Measure |
Adaptive Radiation
n=42 Participants
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
|
68 percentage of patients
Interval 47.0 to 82.0
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SECONDARY outcome
Timeframe: 2 YearsThe number of patients for which dose escalation was possible will be reported.
Outcome measures
| Measure |
Adaptive Radiation
n=42 Participants
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
Number of Patients That Were Able to Receive Dose Escalation
|
42 participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival of all patients will be estimated
Outcome measures
| Measure |
Adaptive Radiation
n=42 Participants
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
Percentage of Patients Alive at 2 Years
|
51 percentage of patients
Interval 34.0 to 65.0
|
SECONDARY outcome
Timeframe: 2 yearsThe number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.
Outcome measures
| Measure |
Adaptive Radiation
n=42 Participants
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
The Number of Participants That Experience Lung Toxicity and Esophagitis
RT-induced lung toxicity
|
8 participants
|
|
The Number of Participants That Experience Lung Toxicity and Esophagitis
esophagitis (grade 2 or greater)
|
13 participants
|
Adverse Events
Adaptive Radiation
Serious events: 29 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adaptive Radiation
n=42 participants at risk
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Asystole
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 2
|
|
Cardiac disorders
Atrial tachycardia
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Bladder infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Bone infection
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
7.1%
3/42 • Number of events 3
|
|
Cardiac disorders
Cardiac pain
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Colitis, infectious (e.g., Clostridium difficile)
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Constitutional Symptoms - Other (Specify)
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
3/42 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
23.8%
10/42 • Number of events 10
|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.9%
5/42 • Number of events 8
|
|
Gastrointestinal disorders
Esophagitis
|
11.9%
5/42 • Number of events 5
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Flu-like syndrome
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Gait abnormal
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Hemorrhage - Other (Specify)
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.5%
4/42 • Number of events 4
|
|
Infections and infestations
Infection - Other (Specify)
|
2.4%
1/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Infection, Lung (pneumonia)
|
11.9%
5/42 • Number of events 8
|
|
Reproductive system and breast disorders
Infection, Prostate
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Joint infection
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Laryngeal edema
|
2.4%
1/42 • Number of events 2
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
4.8%
2/42 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.8%
2/42 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils
|
2.4%
1/42 • Number of events 1
|
|
Investigations
PTT
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.5%
4/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
3/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
9.5%
4/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other(specify)
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Sudden death
|
7.1%
3/42 • Number of events 3
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Voice alteration
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Adaptive Radiation
n=42 participants at risk
Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.1%
3/42 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
3/42 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
9.5%
4/42 • Number of events 7
|
|
Psychiatric disorders
Anxiety
|
9.5%
4/42 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
11.9%
5/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
9.5%
4/42 • Number of events 4
|
|
Cardiac disorders
Cardiac General - Other (Specify)
|
7.1%
3/42 • Number of events 5
|
|
Cardiac disorders
Chest pain
|
11.9%
5/42 • Number of events 7
|
|
Cardiac disorders
Chest wall pain
|
14.3%
6/42 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.0%
13/42 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
21.4%
9/42 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
5/42 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
38.1%
16/42 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.1%
16/42 • Number of events 37
|
|
General disorders
Edema limbs
|
7.1%
3/42 • Number of events 4
|
|
Gastrointestinal disorders
Esophageal pain
|
9.5%
4/42 • Number of events 7
|
|
Gastrointestinal disorders
Esophagitis
|
7.1%
3/42 • Number of events 3
|
|
General disorders
Fatigue
|
40.5%
17/42 • Number of events 32
|
|
General disorders
Fever
|
9.5%
4/42 • Number of events 7
|
|
Nervous system disorders
Headache
|
11.9%
5/42 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin
|
21.4%
9/42 • Number of events 19
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.1%
16/42 • Number of events 38
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.9%
5/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
6/42 • Number of events 9
|
|
Cardiac disorders
Hypotension
|
7.1%
3/42 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytes
|
21.4%
9/42 • Number of events 20
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.5%
17/42 • Number of events 46
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
14.3%
6/42 • Number of events 11
|
|
Blood and lymphatic system disorders
Neutrophils
|
26.2%
11/42 • Number of events 13
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
11.9%
5/42 • Number of events 7
|
|
Blood and lymphatic system disorders
Platelets
|
14.3%
6/42 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
21.4%
9/42 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other(specify)
|
14.3%
6/42 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
28.6%
12/42 • Number of events 20
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
7.1%
3/42 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
7/42 • Number of events 7
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
3/42 • Number of events 5
|
|
General disorders
Weight loss
|
9.5%
4/42 • Number of events 4
|
Additional Information
Dr. Shruti Jolly, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place