Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC

This study has been completed.

Study NCT00226590 Information provided by H. Lee Moffitt Cancer Center and Research Institute

First Received on September 23, 2005. Last Updated on May 23, 2011 History of Changes

Results First Received: March 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Drug: Gemcitabine Drug: Carboplatin Drug: Paclitaxel Procedure: Radiation

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Combination Therapy	In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.

Participant Flow: Overall Study

	Combination Therapy
STARTED	39
COMPLETED	39
NOT COMPLETED	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Combination Therapy	In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.

Baseline Measures

	Combination Therapy
Number of Participants [units: participants]	39
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	29
Gender [units: participants]
Female	20
Male	19
Region of Enrollment [units: participants]
United States	39

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]

Show Outcome Measure 1

2. Secondary:

Progression Free Survival [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]

Show Outcome Measure 2

3. Secondary:

Overall Survival [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]

Show Outcome Measure 3

4. Secondary:

Treatment Completion [ Time Frame: Ranging from 2 weeks up to 4 years, 9 months ]

Show Outcome Measure 4

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gerald Bepler, M.D., Ph.D.
Organization: Karmanos Cancer Institute (formerly at Moffitt Cancer Center)
phone: 313-576-8665
e-mail: beplerg@karmanos.org

No publications provided

Responsible Party:	Gerald Bepler, M.D., Ph.D., Karmanos Cancer Institute
ClinicalTrials.gov Identifier:	NCT00226590 History of Changes
Other Study ID Numbers:	MCC-13240, 13189
Study First Received:	September 23, 2005
Results First Received:	March 11, 2011
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration