Trial Outcomes & Findings for Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer (NCT NCT02157116)

Results Overview

Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Between 2 and 3 weeks after induction

Results posted on

2014-07-04

Participant Flow

This study opened to enrollment in May 2006 and closed in October 2009 due to failure to meet accrual goals for data analysis.

Participant milestones

Participant milestones
Measure	All Subjects All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
Overall Study STARTED	13
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	3
Overall Study Failed Screening	2

Baseline Characteristics

Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=13 Participants All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
Age, Customized <18 years	0 years n=5 Participants
Age, Customized >= 18 years	13 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 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	2 Participants n=5 Participants
Race (NIH/OMB) White	11 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	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Between 2 and 3 weeks after induction

Population: Due to insufficient accrual, data analysis was not performed.

Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at the end of the study, estimated 2.5 years

Population: Due to insufficient accrual, gene analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During induction chemotherapy, approximately 6 weeks

Population: Due to insufficient accrual, data analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During induction chemotherapy, approximately 6 weeks

Population: Due to insufficient accrual, data analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During induction, approximately 6 weeks

Population: Due to insufficient accrual, data analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 10 years

Population: Due to insufficient accrual, the study was stopped prior to completing the 10 year followup for survival.

Outcome measures

Outcome data not reported

Adverse Events

Treated Patients

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

Richard Riedel, MD

Duke University

Phone: 919-681-6932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place