Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03) - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00875901

Purpose

The purpose of this research study is to determine if hypofractionated image guided radiation therapy (hypoIGRT) is a good way to treat lung tumors for patients who will not have surgery. HypoIGRT is a general term for a group of techniques that deliver higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to be better than conventional radiation, because it delivers a more lethal dose of radiation to the tumor, uses more precise set up that decreases the amount of your lung and heart exposed to radiotherapy, and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Radiation: Hypofractionated Image Guided Radiation Therapy Radiation: Hypofractionated Image Guided Radiation Therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Confirm the safety of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess improvements in dosimetric endpoints, acute and late toxicities, disease specific outcomes and quality of life [ Time Frame: Over a 5 year period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	23
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Peripherally located lung tumor	Radiation: Hypofractionated Image Guided Radiation Therapy 12 CGE per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 CGE (Fractions at lest 40 hours apart)
2: Experimental Centrally located lung tumor	Radiation: Hypofractionated Image Guided Radiation Therapy 6 CGE per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 CGE (Fractions at least 24 hours apart)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma (including BAC: bronchial alveolar carcinoma) diagnosed within 3 months prior to study enrollment.
Zubrod performance status 0-3 within 1 month prior to study enrollment.
AJCC Lung 6th Edition, 2002 stage I based on one of the following combinations of TNM staging: Physician documented T1, N0, M0 or T2, N0, M0.
Study-specific informed consent on an IRB-stamped consent prior to any research related procedures or study treatment.
At least 18 years old at the time of consent.
Patients with hilar or mediastinal lymph nodes < 1 cm and without abnormal hilar or mediastinal uptake on PET will be considered N0. Mediastinal lymph node sampling by any technique is allowed but not required.
Patients of child-producing potential (men and women) must agree to use a medically acceptable contraceptive method during study treatment and for at least 12 months after completing study treatment. Please document as such.
Completion of required pretreatment evaluations as listed in section 4.
Tumor < 5 cm.
Adequate bone marrow function defined as follows:
Absolute neutrophil count (ANC) > 1,800 cells/mm3
Platelet count >100,000 cells/mm3
Hemoglobin level >8 g/dl
Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection. Please document their refusal.
If the patient has a large pleural effusion, it must be biopsy negative.

Exclusion Criteria:

Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
Synchronous primary.
Prior invasive malignancy within 3 years.
T2 tumors > 5 cm; T3, T4 primary tumor.
Previous radiotherapy for lung cancer.
Prior chemotherapy for lung cancer.
Prior surgical resection for lung cancer.
Concomitant local, regional, and/or systemic therapy during radiotherapy.
Active systemic, pulmonary, and/or pericardial infection.
Pregnant and/or breast-feeding women. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months. Please document as such.
Major medical, addictive and/or psychiatric illness which, in the investigator's opinion, may prevent the consent process, completion of the study treatment and/or interfere with follow-up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875901

Contacts

Contact: Intake Coordinator

877-686-6009

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator 877-686-6009
Principal Investigator: Bradford S Hoppe, MD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Bradford S Hoppe, MD

University of Florida Proton Therapy Institute

More Information

Additional Information:

Contact the University of Florida Proton Therapy Institute This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party:	University of Florida Proton Therapy Institute ( Bradford S. Hoppe, MD )
Study ID Numbers:	UFPTI 0901 - LU03
Study First Received:	April 2, 2009
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00875901 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Lung Cancer
Stage I Non-Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009