Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02568033|
Recruitment Status : Unknown
Verified July 2016 by The Cooper Health System.
Recruitment status was: Recruiting
First Posted : October 5, 2015
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin Drug: Docetaxel Drug: Paclitaxel Radiation: stereotactic radiosurgery||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
for Non-Squamous Cell: Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of 21 day cycle or Carboplatin AUC6 and Paclitaxel 75 mg/m2 on day 1 of 21 day cycle
for Squamous Cell: Cisplatin 75 mg/m2 and docetaxel 75mg m2 day 1 of 21 day cycle or Carboplatin AUC6 and paclitaxel 200 mg/m2 day 1 of 21 day cycle
Radiation- Stereotactic radiosurgery Peripheral Lung lesion: 60 Gy over 3 fractions Central Lung lesion: 50 Gy over 5 fractions Hilar and Mediastinal LNs 40-50Gy over 5 fractions
2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy.
Other Name: Alimta
Other Name: taxotere
Other Name: taxol
Radiation: stereotactic radiosurgery
Other Name: CK, cyberknife, cyber knife
- Disease free progression [ Time Frame: 4-6 months ]Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.
- Toxicity (Treatment related side effects) [ Time Frame: 4-5 months ]Treatment related side effects will be monitored
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568033
|Contact: Kimberly Krieger||856-735-6237|
|United States, New Jersey|
|MD Anderson Cancer Center at Cooper||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Kim Krieger 856-735-6237|