Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

NCT ID: NCT00614484

Last Updated: 2014-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Proton therapy with chemotherapy

Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.

Proton therapy - 76 Gy in 5 weeks to lung tumor.

Group Type EXPERIMENTAL

Proton Radiation Therapy

Intervention Type RADIATION

A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Taxol

Intervention Type DRUG

200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.

Carboplatin

Intervention Type DRUG

AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Proton Radiation Therapy

A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Intervention Type RADIATION

Taxol

200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.

Intervention Type DRUG

Carboplatin

AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paclitaxel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical stage 2, 3A or 3B (unresectable)
* Histologic evidence of non-small cell carcinoma
* Age \> 18 years
* Karnofsky performance status 70 or greater
* No prior radiation to the chest
* No previous chemotherapy

Exclusion Criteria

* Clinical stage 1 or 4
* Previous malignancies except for non-melanoma skin cancer unless disease free for \> 3 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David A. Bush, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Department of Radiation Medicine

Jerry D. Slater, MD

Role: STUDY_CHAIR

Loma Linda University Department of Radiation Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OSR #49168

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.