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Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

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ClinicalTrials.gov Identifier: NCT02568033
Recruitment Status : Unknown
Verified July 2016 by The Cooper Health System.
Recruitment status was:  Recruiting
First Posted : October 5, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

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.

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568033


Contacts
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Contact: Kimberly Krieger 856-735-6237

Locations
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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
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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT02568033    
Other Study ID Numbers: 13-130
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: July 2016
Additional relevant MeSH terms:
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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