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Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02568033
Enrollment
22
Registered
2015-10-05
Start date
2013-10-31
Completion date
2017-10-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.

Detailed description

Current standard of care for treatment of locally advanced (unresectable stage II and all of stage III) non-small cell lung cancer (NSCLC) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). While outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months. This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses. The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.

Interventions

DRUGPemetrexed
DRUGCarboplatin
DRUGCisplatin
DRUGDocetaxel
DRUGPaclitaxel
RADIATIONstereotactic radiosurgery

Sponsors

The Cooper Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Nonsmall cell lung cancer (NSCLC) (any histology) * unresectable stage II * Stage III * Tumor less than 8 cm * Karnofsky performance scale (KPS) of 50 or better * Three or fewer mediastinal or hilar lymph nodes

Exclusion criteria

* Small cell lung cancer (SCLC) * Stage I and stage IV patients * Stage II patients eligible for surgical resection * Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease. * KPS 40 or less (bed bound) * Tumor size greater than 8 cm * Inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking) * Four or more medisatinal or hilar lymph nodes

Design outcomes

Primary

MeasureTime frameDescription
Disease free progression4-6 monthsLocal control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.
Toxicity (Treatment related side effects)4-5 monthsTreatment related side effects will be monitored

Countries

United States

Contacts

Primary ContactKimberly Krieger
856-735-6237

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026