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Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer


Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin
injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome
measurements of tumor growth and survival will be compared to subjects receiving standard of
care treatment only.


Inclusion Criteria:

Competent adult English speaking subjects

- With limited stage SCLC who have completed standard of care treatment who are
responders with no evidence of disseminated disease other than CNS metastasis,

- With recurrent disseminated SCLC after standard of care treatment with symptoms
related to central tumor obstruction,

- With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously
treated with intratumoral cisplatin

Exclusion Criteria:

- Subjects who do not meet the inclusion criteria

- Subjects who, in the opinion of the investigator, are at risk undergoing a
bronchoscopy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Solid tumor growth after completion of interventional bronchoscopies

Outcome Description:

The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Michael A. Jantz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

SCLC

NCT ID:

NCT01487499

Start Date:

December 2011

Completion Date:

December 2016

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
University of Florida Gainesville, Florida  32610-0277