Status:
COMPLETED
Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC
Lead Sponsor:
Jill Deluca
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Detailed Description
The most common treatment for early stage lung cancers is to remove the cancer with surgery. Patients with serious underlying health problems like emphysema, diabetes, or heart disease who develop an ...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- See inclusion criteria.
- \-
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00246181
Start Date
December 1 1999
End Date
August 1 2012
Last Update
January 13 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University, Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202