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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Docetaxel — DRUG
  Given IV
• Image Guided Radiation Therapy — RADIATION
  Undergo image guided IMRT
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo image guided IMRT
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo standard of care surgery

Study Details

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.

Key Dates

Start date

Mar 12, 2019

Status verified

Apr 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

82 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (surgery, IMRT, cisplatin, carboplatin)
  Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)
  Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Structure preservation rate defined as both skull base and orbit being preserved [ Time Frame: Up to 5 years ]

Locations (140)

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