A Phase I/II Trial of Stereotactic Body Radiation Therapy

Completed · Phase 1/Phase 2

Conditions studied: Inoperable Stage I/II Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00591838

Run by

Washington University School of Medicine

People needed

74

Starts

2006-09-21

Expected to finish

2018-06-12

Last updated by the study team

2019-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (<=7cm), N0, M0
• T3 (<=7cm), N0, M0
• Primary tumor must be arising in one of the following central chest locations:
• Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R \& L main bronchi, R \& L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R \& L lower lobe bronchi])
• Adjacent to (within 5 mm) or invading the mediastinal pleura
• Adjacent to (within 5 mm) or invading the parietal pericardium
• To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease.
• Patients with hilar or mediastinal lymph nodes <=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with >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 <40% predicted; post-operative predicted FEV1 <30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption <50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial.
• Age >=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)

You may not qualify if…

• There is no exclusion criteria associated with this protocol. Please see the above inclusion criteria.-

Where it is running

• Washington University School — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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