Trial Outcomes & Findings for Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC) (NCT NCT01108666)
NCT ID: NCT01108666
Last Updated: 2021-07-07
Results Overview
Ability to successfully plan proton plans
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
10 days
Results posted on
2021-07-07
Participant Flow
Participant milestones
| Measure |
Proton RT and Nelfinavir
Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Proton RT and Nelfinavir
n=7 Participants
Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
67.11 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 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
|
PRIMARY outcome
Timeframe: 10 daysPopulation: The PI has left the institution and despite all possible efforts is not able to be contacted, data are not available to be reported.
Ability to successfully plan proton plans
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 14 daysPopulation: The PI has left the institution and cannot be contacted despite all possible efforts, data are not available to be reported.
Dose limiting toxicities of grade 3 or higher per CTCAE 4.0
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 5 yearsPopulation: Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Late toxicities graded according to the RTOG/EORTC late morbidity scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearPopulation: The PI has left the institution and cannot be contacted despite all possible efforts, data are not available to be reported.
Defined as metabolic response (complete, partial or less than partial) based on PET/CT imaging. Patients are followed for disease recurrence and site (local, regional, distant). Progression-free and overall survival are defined as from start of treatment to first documented recurrence (for PFS), date of death or last patient contact alive.
Outcome measures
Outcome data not reported
Adverse Events
Proton RT and Nelfinavir
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Proton RT and Nelfinavir
n=7 participants at risk
Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
General disorders
Fever
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Lymphocyte count decreased
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
White blood cell decreased
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Renal and urinary disorders
Renal failure
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
Other adverse events
| Measure |
Proton RT and Nelfinavir
n=7 participants at risk
Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Ear and labyrinth disorders
Other Ear and labyrinth disorders
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Dyspepsia
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Dysphagia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Esophageal pain
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Esophagitis
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Gastroparesis
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Oral dysesthesia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
General disorders
Fatigue
|
71.4%
5/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
General disorders
Fever
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
General disorders
Pharyngolaryngeal pain
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Immune system disorders
Alopecia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Infections and infestations
Esophageal infection
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Infections and infestations
Lung infection
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Infections and infestations
Mucosal infection
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Injury, poisoning and procedural complications
Fall
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Blood bilirubin increased
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Lymphocyte count decreased
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Weight gain
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
Weight loss
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Investigations
White blood cell decreased
|
71.4%
5/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Dehydration
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypokalemia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
4/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Psychiatric disorders
Suicidal ideation
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Renal and urinary disorders
Urinary tract pain
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Reproductive system and breast disorders
Epistaxis
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
28.6%
2/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
42.9%
3/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • 10 days
Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place