Trials / Completed

CompletedNCT02262325

Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery

A Phase II Trial Combining Hypofractionated Radiation Boost With Conventionally-Fractionated Chemoradiation in Locally Advanced Non-small Cell Lung Cancer Not Suitable for Surgery

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 21 (actual)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation oncology have allowed better radiation targeting which may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and targeted radiation before standard chemotherapy and radiation therapy may kill more tumor cells and prevent the cancer from coming back in the location in which it started.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the primary tumor control rate at 12 months. SECONDARY OBJECTIVES: I. To further establish safety and tolerability of this regimen. II. To estimate the rates of regional, distant control as well as progression-free survival and overall survival. III. To evaluate the objective response rate (ORR) to this regimen. IV. To evaluate the response of tumors to stereotactic (high-dose) radiation using magnetic resonance tumor perfusion imaging modalities (magnetic resonance \[MR\]-dynamic contrast-enhanced \[DCE\]/perfusion weighted imaging \[PWI\], MR-diffusion, blood oxygenation level dependent \[BOLD\] sequences). OUTLINE: Patients will receive a hypofractionated boost to the primary tumor over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin intravenously (IV) on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. If carboplatin and paclitaxel is administered concurrently with radiotherapy, 2 cycles of carboplatin (AUC=6 mg/min/mL IV on day 1, 22) and paclitaxel (200 mg/m2 IV on day 1, 22) consolidation chemotherapy are required, to be administered starting 4-6 weeks after concurrent chemoradiation has ended. Each cycle is 21 days long. If cisplatin and etoposide is administered concurrently with radiotherapy, consolidation chemotherapy is not allowed. Patients also undergo standard conformal radiation therapy once daily (QD) 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

Type	Name	Description
RADIATION	hypofractionated radiation therapy	Radiation boost in week 1 (days 1-5)
DRUG	cisplatin	Given IV
DRUG	etoposide	Given IV
RADIATION	3-dimensional conformal radiation therapy	Undergo 3-dimensional conformal radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

Start date: 2015-06-08
Primary completion: 2024-04-15
Completion: 2024-04-15
First posted: 2014-10-13
Last updated: 2025-06-12
Results posted: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT02262325. Inclusion in this directory is not an endorsement.