Trial Outcomes & Findings for Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC) (NCT NCT01487499)

Results Overview

The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

18 months

Results posted on

2015-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Limited Stage SCLC Subjects with limited stage SCLC treated sequentially with cisplatin. Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Limited Stage SCLC n=4 Participants Subjects with limited stage SCLC treated sequentially with cisplatin. Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.

The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Limited Stage SCLC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael A. Jantz, MD

University of Florida

Phone: 352-273-8737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place