Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC

NCT00246181 | Completed Phase 1 DMC

• 1 other identifier: 9910-35
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the radiation beams are directed toward the cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancer; stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (1)

• The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer.

  5 years from enrollment completion

Secondary Outcomes (1)

• (2) to see what effects (good and bad) stereotactic radiotherapy has on patients and their cancer.

  5 years from completion enrollment

Interventions

radiation therapy PROCEDURE

Patients will receive 3 fractions

Eligibility Criteria

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

You may qualify if:

• Consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
• All patients must be willing and capable to provide informed consent to participate in the protocol.
• Eligible patients must have appropriate staging studies identifying them as AJCC stage I (T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation will be required by either biopsy or cytology. The following primary cancer types are eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
• The primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR); however, the patient should have underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. Standard "cut-off " guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1 \<40%, post-operative predicted FEV1 \<30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption \<50% predicted.
• Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the PCR and who have no specific accepted medical contraindications for the PCR are not eligible.
• Eligible patients should not have had previous lung or mediastinal radiotherapy.
• There must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. Patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
• Patients must be able to fit inside the stereotactic body frame and able to undergo a CT or MRI scan in the frame.
• The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
• Patients with active systemic, pulmonary, or pericardial infection are ineligible.
• Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
• Patients must be past their 18th birthday at time of registration. Karnofsky performance status \> 60.

Sponsors & Collaborators

• Jill Deluca: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University, Department of Radiation Oncology

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Henderson M, McGarry R, Yiannoutsos C, Fakiris A, Hoopes D, Williams M, Timmerman R. Baseline pulmonary function as a predictor for survival and decline in pulmonary function over time in patients undergoing stereotactic body radiotherapy for the treatment of stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):404-9. doi: 10.1016/j.ijrobp.2007.12.051. Epub 2008 Apr 18.

  PMID: 18394819 DERIVED

Related Links

• Link to Department of Radiation Oncology

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ronald McGarry, MD

  Indiana University - Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Achilles Fakiris, MD

  Indianan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: December 1, 1999
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)