Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02568033
• Other study ID #: 13-130
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2015
• Last updated: January 30, 2017
• Start date: October 2013
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: The Cooper Health System
• Contact: Kimberly Krieger
• Phone: 856-735-6237
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed

• Carboplatin

• Cisplatin

• Docetaxel

• Paclitaxel

Radiation:
• stereotactic radiosurgery

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free progression	Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.	4-6 months
Primary	Toxicity (Treatment related side effects)	Treatment related side effects will be monitored	4-5 months