Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.

Key facts

Study ID

NCT03699033

Run by

Stephanie Smiddy

People needed

0

Starts

2018-10-01

Expected to finish

2020-10-01

Last updated by the study team

2020-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
• Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
• No PET/CT evidence of metastatic disease.
• An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
• If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
• Subjects must have measurable or evaluable disease.
• No prior thoracic radiotherapy.
• Age > 18 years at time of registration.
• ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
• Hgb > 9 g/dL; ANC (absolute neutrophil count) > 1500/µl; platelets > 100,000 mcL.
• Subjects must sign study-specific informed consent form prior to registration.
• Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.

You may not qualify if…

• Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
• Active connective tissue disorders, such as active lupus or scleroderma.
• Known Acquired Immune Deficiency (HIV (+)/AIDS).
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Where it is running

• University of Toledo, Eleanor N. Dana Cancer Center — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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