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

NCT00614484 | Terminated Phase 1 Results DMC

• 1 other identifier: OSR #49168
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Non-Small Cell Lung Cancer

Keywords

Proton; Radiation

Outcome Measures

Primary Outcomes (1)

• Overall Survival.

  Median survival time following treatment.

  Monthly for duration of participant lifespan. Average lifespan 1-2 years

Secondary Outcomes (1)

• Treatment Related Toxicities.

  Monthly for duration of participant lifespan. Average lifespan 1-2 years

Study Arms (1)

Proton therapy with chemotherapy

EXPERIMENTAL

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.

Radiation: Proton Radiation Therapy; Drug: Taxol; Drug: Carboplatin

Interventions

Proton Radiation Therapy 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.

Proton therapy with chemotherapy

Taxol DRUG

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

Also known as: Paclitaxel

Proton therapy with chemotherapy

Carboplatin DRUG

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

Proton therapy with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Protons; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Limitations and Caveats

Slow enrollment over a long time period limits the conclusions that can be drawn.

Results Point of Contact

• Title: David Bush MD
• Organization: Professor of Radiation Medicine, Loma Linda University Medical Center

dbush@llu.edu

909-558-4280

Study Officials

• David A. Bush, MD

  Loma Linda University Department of Radiation Medicine

  PRINCIPAL INVESTIGATOR

• Jerry D. Slater, MD

  Loma Linda University Department of Radiation Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: February 13, 2008
• Study Start: August 1, 1999
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 22, 2014
• Results First Posted: May 22, 2014

Record last verified: 2014-04

Locations

US (1)