Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03493425 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT03493425: Recruiting Phase 2 study of Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.
NCT03493425 is a Phase 2 study of Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7 that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03493425, a Phase 2 study of Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Fisher's exact test will be used to compare the structure preservation rate between the two arms. The comparison between the two arms for structure preservation will be conducted separately (each at one-sided 0.05 significance level).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What NCT03493425 shows while recruiting
NCT03493425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
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.
NCT03493425 names 20 study sites across 7 states, led by Florida, Arizona, California.
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.
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).
Who is sponsoring clinical trial NCT03493425?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03493425's enrollment target sits among peer trials
82 830th of 2000 higher than 1,168 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03319901 · 82 participants · Phase 1
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
- NCT04105270 · 82 participants · Phase 2
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
- NCT04428658 · 82 participants · NA
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
- NCT04449549 · 82 participants · Phase 2
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI