Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

NCT ID: NCT02568033

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

stereotactic radiosurgery

Intervention Type: RADIATION

Interventions

Pemetrexed

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

stereotactic radiosurgery

Intervention Type: RADIATION

Other Intervention Names

Alimta; taxotere; taxol; CK, cyberknife, cyber knife

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimberly Krieger

Role: CONTACT

856-735-6237

Facility Contacts

Kim Krieger

Role: primary

856-735-6237

References

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.

Reference Type: DERIVED

PMID: 35195562 (View on PubMed)

Other Identifiers

13-130

Identifier Type: -

Identifier Source: org_study_id