A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography
OBJECTIVES:
Primary
- To determine progession free survivial rates in patients with inoperable stage IA and
select stage IB non-small cell lung cancer treated with external-beam radiation therapy
and radiofrequency ablation (RFA).
Secondary
- To determine the acute and late toxicity of combining RFA with external-beam radiation
therapy.
- To determine the patterns of failure at time of first relapse.
- To determine the rate of overall survival at 1 and 2 years after treatment.
- To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior
to RFA to predict local control and time to progression.
- To measure post RFA/simulation (treatment planning) PET max and peak SUV's and
correlate this data with local control at 1 and 2 years.
- To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly
after radiotherapy (post-treatment) to predict local control and time to progression.
- To evaluate PET-CT data and its utility in guiding radiation therapy treatment
planning.
- To explore the use of dual time point imaging PET data obtained to predict local
control and also to differentiate between recurrence versus inflammation when
applicable.
- To assess physical function as a prognostic measure, and to determine the impact of
treatment on physical function.
- To evaluate the impact of treatment on generic and disease-specific quality of life.
OUTLINE: Patients undergo fludeoxyglucose F18 positron emission tomography (FDG-PET) and CT
scan at baseline. Patients then undergo radiofrequency ablation (RFA). Beginning within 5
weeks after completion of RFA, patients undergo external-beam radiation therapy once daily,
5 days a week, for 5-6 weeks. FDG-PET/CT scan is repeated 3-4 weeks after RFA and 12-16
weeks after completion of external-beam radiation therapy.
Quality of life is assessed at baseline, during treatment, and at 16 weeks and at 1 year
after completion of treatment.
After completion of study treatment, patients are followed periodically for 2 years.
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Cytology or biopsy-proven disease
- Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural
involvement or size ≥ 3.0 cm)
- Tumor size ≤ 3.5 cm
- No bronchioloalveolar carcinoma
- Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no
clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas
- Patients with > 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will
still be eligible if directed tissue biopsy or needle aspiration of abnormally
identified area are negative for cancer
- Patients with > 1.5 cm and < 2.0 cm lymph nodes and no clinically suspicious
FDG-PET uptake in those areas will still be eligible
- All patients are required to have been evaluated by a thoracic surgeon and have
either refused surgery or been deemed medically inoperable due to comorbid conditions
- CT images of the chest must be reviewed by an experienced interventional radiologist
and the target lesion must be determined to be in a location where radiofrequency
ablation is technically achievable based on the proximity of adjacent organs and
structures
- Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should
have biopsy if possible
- If the biopsy is positive, the patient should be treated as per the clinician's
preference off of this protocol
- If the biopsy is negative and representative of the lesion in question then the
patient may be treated as per this protocol
- If the biopsy is non-diagnostic, consideration should be given to repeat biopsy
- If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the
patient will not be eligible for this protocol and should be treated per the
clinician's preference
PATIENT CHARACTERISTICS:
-
Inclusion Criteria:
- ECOG performance status 0-2
- Women of childbearing potential must have a negative pregnancy test
- Fertile women must use effective contraception
- Exclusion Criteria:
- History of prior malignancy within the past 2 years except for curatively
treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia,
T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a
current PSA level < 1.0 mg/dL on 2 successive evaluations, at least 3 months
apart, with the most recent evaluation no more than 4 weeks prior to study entry
- Pregnant or lactating women
PRIOR CONCURRENT THERAPY:
- Exclusion Criteria:
- Previous chest radiation to the lung or mediastinum
- Patients must not receive other concurrent anticancer therapies while on
protocol including any of the following:
- Radiotherapy
- Radiofrequency ablation
- Other antineoplastic interventional radiology techniques
- Chemotherapy
- Biological therapy
- Vaccine therapy
- Surgery
- Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial
cell carcinoma allowed
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Two Year Progression Free Survival Rate
Outcome Description:
the number of patients surviving progression-free at two years.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Hollins Clark, MD, MS
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000555009
NCT ID:
NCT00499447
Start Date:
May 2007
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- adenocarcinoma of the lung
- adenosquamous cell lung cancer
- large cell lung cancer
- squamous cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
