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RECRUITING Phase 2

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

NCT03493425 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin 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 and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.

Interventions

  • DRUG Carboplatin
  • DRUG Docetaxel
  • DRUG Cisplatin
  • RADIATION Intensity-Modulated Radiation Therapy
  • RADIATION Image Guided Radiation Therapy

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
  • Moffitt Cancer Center-International Plaza — Tampa
  • Moffitt Cancer Center - McKinley Campus — Tampa
  • Moffitt Cancer Center — Tampa

Arizona

  • University of Arizona Cancer Center-Orange Grove Campus — Tucson
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

California

  • UC San Diego Moores Cancer Center — La Jolla
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • VA Palo Alto Health Care System — Palo Alto

Georgia

  • Emory Proton Therapy Center — Atlanta
  • Emory University Hospital Midtown — Atlanta
  • Emory University Hospital/Winship Cancer Institute — Atlanta

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital — New Haven
  • Yale University — New Haven

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith

Idaho

  • Saint Alphonsus Cancer Care Center-Boise — Boise

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2019-03-12
Est. Completion 2029-03-31
Phase Phase 2

Sponsor

ECOG-ACRIN Cancer Research Group

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03493425

The ClinicalTrials.gov registry entry for NCT03493425 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03493425 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03493425 about?

NCT03493425 is a clinical study titled "Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery". This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin,...

What is the current status of trial NCT03493425?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2019-03-12. Estimated completion is 2029-03-31.

What conditions does trial NCT03493425 study?

This clinical trial studies the following conditions: Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03493425?

The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Cisplatin (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Image Guided Radiation Therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03493425?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03493425 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial