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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

General physical condition compatible with the proposed chemotherapy and surgery

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Carboplatin
  • Cisplatin
  • Docetaxel
  • Image Guided Radiation Therapy
  • Intensity-Modulated Radiation Therapy
  • Laboratory Biomarker Analysis
  • Questionnaire Administration
  • Therapeutic Conventional Surgery

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator