Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2017 |
| Start Date: | October 2013 |
| End Date: | October 2017 |
| Contact: | Kimberly Krieger |
| Phone: | 856-735-6237 |
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
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.
to treat stage II and III lung cancer that is not amendable to surgical resection.
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.
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.
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
We found this trial at
1
site
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