Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

• ClinicalTrials.gov Identifier: NCT02568033
• Recruitment Status: Unknown
• First Posted: October 5, 2015
• Last Update Posted: January 31, 2017
• Sponsor: The Cooper Health System
• Information provided by (Responsible Party): The Cooper Health System

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Drug: Pemetrexed; Other Name: Alimta; Drug: Carboplatin; Drug: Cisplatin; Drug: Docetaxel; Other Name: taxotere; Drug: Paclitaxel; Other Name: taxol; Radiation: stereotactic radiosurgery; Other Name: CK, cyberknife, cyber knife

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Toxicity (Treatment related side effects) [ Time Frame: 4-5 months ]
   Treatment related side effects will be monitored

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Kimberly Krieger; 856-735-6237

Locations

United States, New Jersey

MD Anderson Cancer Center at Cooper; Recruiting

Camden, New Jersey, United States, 08103

Contact: Kim Krieger 856-735-6237

Sponsors and Collaborators

The Cooper Health System

More Information

• Responsible Party: The Cooper Health System
• ClinicalTrials.gov Identifier: NCT02568033
• Other Study ID Numbers: 13-130
• First Posted: October 5, 2015
• Last Update Posted: January 31, 2017
• Last Verified: July 2016

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Paclitaxel; Docetaxel; Cisplatin; Carboplatin; Pemetrexed; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors