Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer

Official Summary

This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 20 participants

Interventions

• OTHER: Laboratory Biomarker Analysis — Correlative studies
• OTHER: Quality-of-Life Assessment — Ancillary studies
• DRUG: Stereotactic Body Radiation Therapy — Undergo lowest-dose of SBRT
• DRUG: Stereotactic Body Radiation Therapy — Undergo lowest- or higher-dose of SBRT
• DRUG: Stereotactic Body Radiation Therapy — Undergo highest-dose of SBRT

Primary Outcomes

• Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 (Up to 10 weeks post-surgery)

Secondary Outcomes

• Overall survival (Up to 5 years)
• Progression free survival (Up to 5 years)

Eligibility Criteria

Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)

  * Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
  * Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for \>3 years
* Participant is able to undergo surgery (planned lobectomy or wedge resection)

  * Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly)
* Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
* Previous surgery for this lung or mediastinum tumor
* Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression
* Patients with active systemic, pulmonary, or pericardial infection
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator?s opinion deems the participant ineligible
* Received an investigational agent within 30 days prior to enrollment
* Stage IIIb

Trial Locations

• Roswell Park Cancer Institute, Buffalo, New York, United States

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