Trial Outcomes & Findings for Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer (NCT NCT01797471)
NCT ID: NCT01797471
Last Updated: 2017-12-21
Results Overview
Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.
TERMINATED
NA
1 participants
Up to 12 months
2017-12-21
Participant Flow
Participant milestones
| Measure |
LEAD RT
* Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;
* Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;
* Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
LEAD RT
n=1 Participants
* Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;
* Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;
* Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Study participants experiencing treatment-related esophagitis or pneumonitis.
Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.
Outcome measures
| Measure |
LEAD RT
n=1 Participants
* Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;
* Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;
* Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
|
|---|---|
|
Rate of Treatment-related Toxicity in Study Participants
Esophagitis
|
1 Participants
|
|
Rate of Treatment-related Toxicity in Study Participants
Pneumonitis
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 2 yearsPopulation: A minimum sample size of 10 study participants was required for the analysis of the outcome. Minimum enrollment was not met, therefore, the data were not analyzed.
Number of subjects achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria on CT Scan: * CR: Complete disappearance of all disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline. * PR: Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 2 yearsPopulation: A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.
Rate of subjects achieving complete response (CR) or partial response (PR) as detected by positron emission tomography (PET) Scan: * CR is defined as no residual focal fluorodeoxyglucose (FDG) uptake or decrease in average FDG uptake by more than 80% in all tumor manifestations. * PR is defined as standardized uptake value (SUV) decrease by 0 - 80%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 2 yearsPopulation: A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.
Rate of loco-regional failure in study participants. Loco-regional failure is defined as any evidence of disease progression within the primary primary tumor or regional lymph nodes, detected by any method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 2 yearsPopulation: A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.
Rate of progression-free survival (PFS). PFS is defined as the length of time from date of treatment initiation until date of documented disease progression or death from any cause, with censoring of patients who are lost to follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 2 yearsPopulation: A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.
Rate of overall survival (OS) in study participants. Overall survival is defined as the length of time from the date of treatment initiation until the date of death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
LEAD RT
Serious adverse events
| Measure |
LEAD RT
n=1 participants at risk
* Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;
* Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;
* Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal hemorrhage
|
100.0%
1/1 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
100.0%
1/1 • Number of events 1
|
Other adverse events
| Measure |
LEAD RT
n=1 participants at risk
* Lattice Extreme Ablative Dose Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by;
* Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy;
* Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Lattice Extreme Ablative Dose Radiation Therapy: A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place