Recruiting
Early Phase 1

Chemotherapy & HFR Radiation

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT02619448

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Paclitaxel

70 Gy in 20 fractions over 4 weeks

Study Details

Brief summary:

The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT02619448

Start date

Dec, 2014

Status verified date

Mar, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically or cytologically proven diagnosis of non-small cell lung carcinoma.
  • Solitary \[T1bN0M0, T2aN0M0, T2bN0M0\] lesion measuring 2-7cm in size. Staging is per AJCC 7th edition of TNM classification.
  • Patient must meet criteria for receipt of hypofractionated radiation therapy
  • Medically inoperable pulmonary status, cardiac status, or other serious co-morbidity, or patient refusal of primary surgery for lung cancer.
  • ECOG Performance status of 0-2.
  • Patients may have prior treatment for lung cancer based on the following criteria:

1. Surgical resection is allowed if surgery was > 12 months ago.
2. Patients treated with prior radiation are eligible if radiation was > 12 months ago and there is no evidence of progression and if the lesion is in a different lobe.
3. Prior chemotherapy if > 18 months ago

Exclusion Criteria:

  • Node positive or metastatic disease.
  • Other active malignancy (specifically, risk of recurrence in 3 years estimated to be greater than 50%) except for non-melanoma skin cancer, in-situ cervical carcinoma (CIN), or low-risk prostate carcinoma on active surveillance are to be excluded.
  • Inability to receive systemic therapy or radiation therapy per protocol.
  • Inability to fulfill requirements of the protocol.
  • Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chemotherapy with hypofractionated RT

Carboplatin AUC 2 + Paclitaxel 50 mg/m2 given weekly x 4 concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks

Interventions

Carboplatin

chemotherapy

Paclitaxel

chemotherapy

70 Gy in 20 fractions over 4 weeks

accelerated hypofractionated RT

Primary outcome measure

  • Toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Erin Bingham, BS

3154643603binghame@upstate.edu

Sherice Simpson, MS

3154645934simpsons@upstate.edu

Locations

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Erin Bingham, BS

315-464-3603binghamE@upstate.edu

Sherice Simpson, MS

315-464-5934simpsons@upstate.edu

Principal Investigator:

Michael Mix, MD

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Mar 25, 2024

Last verified

Mar, 2024

Keywords

  • inoperable
  • Solitary [T1bN0, T2aN0, T2bN0] lesion measuring 2-7 cm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2024-03-25.