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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events
Secondary outcome measures
PET/CT scan
Local progression as measured by PET/CT
Overall survival as determined by patient contact
+3 more

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
173 Previous Clinical Trials
27,380 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
Non-Small Cell Lung Cancer Research Study Groups: Chemotherapy with hypofractionated RT
Non-Small Cell 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies has Paclitaxel been traditionally prescribed for?

"Paclitaxel is the go-to medication for treating melanoma. Moreover, it can also assist with other diseases such as metastasized neoplasms, lymphomas, non-Hodgkin's malignancies and advanced sarcoma."

Answered by AI

Are there still openings for volunteers in this trial?

"This clinical study, initially released on December 1st 2014 and most recently updated May 1th 2018, is seeking participants. Clinicaltrials.gov has the information available for public viewing."

Answered by AI

How many participants are enrolled in this investigation?

"Affirmative. The clinical trial directory on clinicaltrials.gov shows that recruitment for this medical study is active - it was initially posted on December 1st 2014 and its information has been recently updated as of May 1st 2018. At present, 12 participants need to be found from a single clinic site."

Answered by AI

Has Paclitaxel been evaluated in other clinical trials?

"At present, there are 1175 active Paclitaxel studies with 332 of those in the 3rd phase. Notably, Shanghai alone has several clinical trials while globally 66531 different locations have a trial running for this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
2014. "Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02619448.
All > Metastatic Lung Cancer > Lung Cancer
~0 spots leftby Jul 2024
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