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Platinum-based Chemotherapy

Chemotherapy + High-Dose Radiation for Lung Cancer

Phase < 1
Recruiting
Led By Michael Mix, MD
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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
Node positive or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with early stage lung cancer who cannot have surgery. The goal is to see if it is a good option for these patients.

Who is the study for?
This trial is for patients with a type of lung cancer called NSCLC who can't have surgery due to other health issues or personal choice. They should be relatively active (ECOG 0-2), may have had surgery over a year ago, and any previous radiation or chemo must also be more than a year old. The cancer should not have spread to lymph nodes or elsewhere, and the tumor size needs to fit specific criteria.
What is being tested?
The study tests if high-dose radiation therapy given in fewer treatments (70 Gy in 20 fractions over 4 weeks) combined with chemotherapy drugs Carboplatin and Paclitaxel is effective for NSCLC patients who cannot undergo surgery. It aims to evaluate side effects and potential as a definitive treatment.
What are the potential side effects?
Possible side effects include reactions related to chemotherapy like nausea, hair loss, low blood counts leading to increased infection risk, fatigue, and nerve damage. Radiation might cause skin irritation at the site of treatment, difficulty swallowing if near the esophagus, and lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed to be non-small cell type.
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My cancer is in an early stage and the tumor is 2-7cm big.
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I cannot undergo lung cancer surgery due to health issues or personal choice.
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I can take care of myself and perform daily activities.
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I am eligible for a shorter course of radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have another cancer with a high risk of returning, except for certain skin, cervical, or low-risk prostate cancers.
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My cancer has spread to lymph nodes or other parts of my body.
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I cannot undergo standard chemotherapy or radiation as per the study's guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemotherapy with hypofractionated RTExperimental Treatment3 Interventions
Carboplatin AUC 2 + Paclitaxel 50 mg/m2 given weekly x 4 concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

State University of New York - Upstate Medical UniversityLead Sponsor
174 Previous Clinical Trials
27,458 Total Patients Enrolled
Michael Mix, MDPrincipal InvestigatorState University of New York - Upstate Medical University

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02619448 — Phase < 1
Lung Cancer Research Study Groups: Chemotherapy with hypofractionated RT
Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02619448 — Phase < 1
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02619448 — Phase < 1
~1 spots leftby Dec 2025
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