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Platinum-based Chemotherapy

Pre-Surgery Chemotherapy + Surgery & Radiation for Sinus Cancer

Phase 2

Recruiting

Led By Nabil Saba

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection

Must not have

Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded

Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well chemotherapy works with surgery and radiation therapy compared to surgery and radiation therapy alone for nasal and paranasal sinus cancer.

Who is the study for?

This trial is for adults with nasal and paranasal sinus cancer that can be surgically removed. They should not have had prior radiation for head or neck tumors, no severe allergies to the chemo drugs used, and no other cancers in the last 2 years (except certain skin cancers). Participants need functioning major organs, no serious illnesses that could affect treatment, and women must not be pregnant.

What is being tested?

The study compares two approaches: one group receives chemotherapy (docetaxel, cisplatin, carboplatin) before surgery and radiation therapy; the other has surgery followed by radiation only. The goal is to see if pre-surgery chemo makes tumors smaller and reduces how much normal tissue needs removal.

What are the potential side effects?

Chemotherapy may cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. Radiation might lead to skin irritation at the treated site or fatigue. Surgery risks include bleeding and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced and requires surgery near the eye or skull.

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My surgery team considers my condition operable, with expectations for preserving key facial structures.

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I had skin or cervical cancer before, but it was successfully treated.

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I am not pregnant or breastfeeding.

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I do not have severe numbness or pain in my hands or feet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cancer that has spread far or to the lining of my brain.

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I have not had radiation for tumors in my head, neck, skull base, or brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Structure preservation rate defined as both skull base and orbit being preserved

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)Experimental Treatment8 Interventions

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.

Group II: Arm A (surgery, IMRT, cisplatin, carboplatin)Active Control7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Cisplatin

2013

Completed Phase 3

~3120