Clinical trial NCT02568033: Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
Official title: Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease free progression
timeFrame: 4-6 months
measure: Toxicity (Treatment related side effects)
timeFrame: 4-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
Study officials:
References:
citation: Kubicek GJ, Khrizman P, Squillante C, Callahan K, Xu Q, Abouzgheib W, Boujaoude Z, Patel A, Hageboutros A. Stereotactic Body Radiotherapy and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer: Single Arm Phase 2 Study. Am J Clin Oncol. 2022 Mar 1;45(3):129-133. doi: 10.1097/COC.0000000000000892.