Phase 2
Completed N=74
A Phase I/II Trial of Stereotactic Body Radiation Therapy
Inoperable Stage I/II Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00591838 ↗
Enrolled (actual)
74
Serious AEs
47.3%
Results posted
Jul 2019
Primary outcomePrimary: Phase I Portion Only: Determine the Maximum Tolerated Dose of SBRT — 11 Gy x 5 fractions
Summary
The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I Portion Only: Determine the Maximum Tolerated Dose of SBRT |
11 | — |
| PRIMARY Phase I Portion Only: Number of Participants With Acute Treatment Related Grade 3-5 Toxicity |
0; 1; 0; 0; 0; 1 | — |
| PRIMARY Phase I Portion Only: Number of Participants With Late Treatment Related Grade 3-5 Toxicity |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Phase II Portion Only: Local Control Rate |
85 | — |
| SECONDARY Phase II Only: Regional Nodal Recurrence Rate |
— | — |
| SECONDARY Phase II Only: Disseminated Recurrence Rate |
27 | — |
| SECONDARY Phase II Only: Disease-free Survival Rate |
28 | — |
| SECONDARY Phase II Only: Overall Survival Rate |
43 | — |
Eligibility Criteria
ELIGIBILITY:
Inclusion Criteria
- Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed.
- Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:
- T1, N0, M0
- T2 ( 1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.
- Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 =18.
- Zubrod performance status 0-2.
- Women of childbearing potential must use effective contraception.
- No direct evidence of regional or distant metastases after appropriate staging studies. No synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancer.
- No previous lung or mediastinal radiation therapy.
- No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemo, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.
- No active systemic, pulmonary, or pericardial infection.
- No pregnant or lactating women.
- PRESTUDY REQUIREMENTS:
- History and Physical Examination, Weight, Zubrod performance status (within 4 weeks pre-study entry)
- Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry)
- Pregnancy test, if applicable (serum or urine, within 72 hours prior to treatment start.)
- CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals)
- PET (using FDG with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions)
- Brain MRI or head CT with contrast
- PFTs - include routine spirometry, lung volumes, diffusion capacity
- Signed informed consent.
Exclusion Criteria
There is no exclusion criteria associated with this protocol. Please see the above inclusion criteria.-
Data sourced from ClinicalTrials.gov (NCT00591838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.