Trial Outcomes & Findings for Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM (NCT NCT03705351)
NCT ID: NCT03705351
Last Updated: 2024-03-04
Results Overview
Number of patients who experienced a treatment-related adverse event
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
15 Weeks (8 weeks after completion of trimodal therapy)
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
Safety lead-in Cohort
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Safety lead-in Cohort
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Overall Study
Study termination
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM
Baseline characteristics by cohort
| Measure |
Safety lead-in Cohort
n=7 Participants
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Age, Continuous
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Karnofsky Performance Scale (KPS)
KPS 70: Cares for self; unable to carry on normal activity or to do active work
|
1 Participants
n=5 Participants
|
|
Karnofsky Performance Scale (KPS)
KPS 80: Normal activity with effort; some signs or symptoms of disease
|
3 Participants
n=5 Participants
|
|
Karnofsky Performance Scale (KPS)
KPS 90: Able to carry on normal activity, minor signs or symptoms of disease
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 Weeks (8 weeks after completion of trimodal therapy)Number of patients who experienced a treatment-related adverse event
Outcome measures
| Measure |
Safety lead-in Cohort
n=7 Participants
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy
|
2 Participants
|
PRIMARY outcome
Timeframe: 15 weeks (8 weeks after completion of trimodal therapy)Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
Outcome measures
| Measure |
Safety lead-in Cohort
n=7 Participants
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 106Number of patients alive at Day 106 (15 weeks), end of main study period
Outcome measures
| Measure |
Safety lead-in Cohort
n=7 Participants
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Overall Survival Rate
Number of participants not evaluated due to being withdrawn from study prior to Day 106
|
2 Participants
|
|
Overall Survival Rate
Number of participants alive at Day 106
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months and 24 monthsNumber of patients who are progression free at 6 months and 24 months. Progression is defined as any of the following: greater than or equal to 25% increase in sum of lesions compared with smallest tumor measurement obtained, significant increase in T2/FLAIR non-enhancing lesions, any new lesion, clear clinical deterioration not attributable to other causes, or clear progression of non-measureable disease.
Outcome measures
| Measure |
Safety lead-in Cohort
n=7 Participants
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Progression-free Survival at 6 Months and 24 Months
Number of participants progression-free at 6 months
|
3 Participants
|
|
Progression-free Survival at 6 Months and 24 Months
Number of participants progression-free at 24 months
|
NA Participants
Study terminated prior to any patient reaching Month 24
|
Adverse Events
Safety lead-in Cohort
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Safety lead-in Cohort
n=7 participants at risk
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia - worsened
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Decreased lymphocytopenia
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
Other adverse events
| Measure |
Safety lead-in Cohort
n=7 participants at risk
Participants who finished the DLT period and were assessed by investigators
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Blood and lymphatic system disorders
Anemia (decreased hemoglobin)
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Blood and lymphatic system disorders
Pain in lymph node, right cervical region
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Blood and lymphatic system disorders
Enlarged lymph node right cervical region
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Blood and lymphatic system disorders
Thrombocytopenia - worsened
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Eye disorders
Eye strain - right eye
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Eye disorders
Right Field Cut
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Gastrointestinal disorders
Mild constipation
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 4 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Gastrointestinal disorders
Nausea - worsened from baseline
|
14.3%
1/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
General disorders
Fatigue in evenings
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
General disorders
Generalized fatigue
|
42.9%
3/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
General disorders
Impaired tandem gait
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Immune system disorders
Allergic reaction due to OPTUNE - rash - diffuse
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Immune system disorders
Allergic reaction - rash, diffuse unknown origin
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Immune system disorders
Itching due to allergic reaction - diffuse, unknown origin
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Infections and infestations
Conjunctivitis in left eye
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Injury, poisoning and procedural complications
Bruising on abdomen, secondary to itching
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Injury, poisoning and procedural complications
Scabs on knees from falls
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Increased ALT
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Increased creatinine
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Increased glucose
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Decreased albumin
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Decreased calcium
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Decreased lymphocytes
|
14.3%
1/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Investigations
Lymphocytes, decreased
|
14.3%
1/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Metabolism and nutrition disorders
Slight weight gain
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Metabolism and nutrition disorders
Weight loss
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Dull, throbbing headached - lower right side back of head
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Dysphasia
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Facial Muscle Weakness (Left Side)
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Headaches - intermittent
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Headache - worsened from baseline
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Imbalance
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Left sided weakness
|
14.3%
1/7 • Number of events 3 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Memory Impairment
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Seizures
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Tingling - right side of face
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Tingling in fingers - both hands
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Twitch on top of head - intermittent
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Nervous system disorders
Worsening Imbalance
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Blisters on scalp - diffuse
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Dry skin on scalp - front left side
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Dryness of skin on scalp - diffuse
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Dryness on scalp - diffuse
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Edema - scalp - right side
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema, scalp
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema of temples
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema on scalp - front left side
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema scalp - circumferential under diodes
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Erythema scalp - diffuse
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Folliculitis - back of hand
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Folliculitis on lower back of head
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Itching on scalp - diffuse
|
14.3%
1/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Itchy scalp - location not specified
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Moist dsequamation - right side of head
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Scalp blisters - diffuse
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Scalp peeling - left frontal lobe
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
28.6%
2/7 • Number of events 2 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Three open sores on front left side of scalp
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
|
Skin and subcutaneous tissue disorders
Two blisters on the back of head
|
14.3%
1/7 • Number of events 1 • 15 weeks (8 weeks after completion of trimodal therapy)
|
Additional Information
Chiayi Chen / Director of PBSI and WC Clinical Research Program
Providence Health & Services
Phone: (503) 216-1012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place