Trial Outcomes & Findings for The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00887315)

Results Overview

Overall survival is assessed at 1 year from the date of study enrollment to date of death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline to death from any cause, 1 year

Results posted on

2013-12-06

Participant Flow

Funding was withdrawn before conclusions were reached so the study was terminated.

Participant milestones

Participant milestones
Measure	Chemo Only Chemotherapy only	Chemo and Radiation Chemotherapy and hypofractionated image guided radiotherapy
Overall Study STARTED	7	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemo Only Chemotherapy only	Chemo and Radiation Chemotherapy and hypofractionated image guided radiotherapy
Overall Study Study termination	7	4

Baseline Characteristics

The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemo Only n=7 Participants Chemotherapy only	Chemo and Radiation n=4 Participants Chemotherapy and radiotherapy	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	66.4 years STANDARD_DEVIATION 10.6 • n=5 Participants	74 years STANDARD_DEVIATION 3.2 • n=7 Participants	69.1 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to death from any cause, 1 year

Population: The study was terminated before conclusions were reached so no data was analyzed.

Overall survival is assessed at 1 year from the date of study enrollment to date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: >90 days

Population: The study was terminated before conclusions were reached so no data was analyzed.

Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (\>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines

Outcome measures

Outcome data not reported

Adverse Events

Chemo Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemo and Radiation

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

Dr. Sang Mee Lee

Department of Health Studies, University of Chicago

Phone: 773-834-6765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place