NCT03493425 · ECOG-ACRIN Cancer Research Group
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
What this study is about
This randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Carboplatin
Given IV
DRUG
Cisplatin
Given IV
DRUG
Docetaxel
Given IV
RADIATION
Image Guided Radiation Therapy
Undergo image guided IMRT
RADIATION
Intensity-Modulated Radiation Therapy
Undergo image guided IMRT
OTHER
Laboratory Biomarker Analysis
Correlative studies
OTHER
Questionnaire Administration
Ancillary studies
PROCEDURE
Therapeutic Conventional Surgery
Undergo standard of care surgery
Primary outcome measures
Structure preservation rate defined as both skull base and orbit being preserved
Time frame: Up to 5 years
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).
Overall survival (OS)
Time frame: From date of randomization, censoring follow-up at last date of contact, assessed for up to 5 years
Log rank test will be used to compare OS between the two arms. The comparison between the two arms for OS will be conducted separately (each at one-sided 0.05 significance level).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- General physical condition compatible with the proposed chemotherapy and surgery
- Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection:
- Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection
- The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B
- Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base; or for ethmoid sinus or frontal sinus involvement
- Resection of orbital contents will be deemed necessary according to skull base society guidelines, based
Where
- Tucson, Arizona
- Fort Smith, Arkansas
- La Jolla, California
- Palo Alto, California
- New Haven, Connecticut
- Coral Gables, Florida
- Deerfield Beach, Florida
- Miami, Florida
- Plantation, Florida
- Tampa, Florida
- Atlanta, Georgia
- Boise, Idaho
And 94 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations