Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

Cooper University Health Care

Status and phase

Unknown

Early Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Radiation: stereotactic radiosurgery

Drug: Cisplatin

Drug: Carboplatin

Drug: Docetaxel

Drug: Paclitaxel

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT02568033

13-130

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Experimental group

Description:

Chemotherapy: 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 Schedule is: 2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy.

Treatment:

Drug: Pemetrexed

Drug: Paclitaxel

Drug: Docetaxel

Drug: Cisplatin

Radiation: stereotactic radiosurgery

Drug: Carboplatin