Trial Outcomes & Findings for Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer (NCT NCT00043108)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

5 years

Results posted on

2022-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	17 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Toxic Death Rate	NA Participants The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Complete Resection Rates	NA Participants The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Survival	NA months The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Event-free Survival	NA months The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Pathologic Complete Remission (pCR)	NA Participants The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Hallman

Fox Chase Cancer Center

Phone: 215-728-2581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place