← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is advanced and requires surgery near the eye or skull.
Select...
My surgery team considers my condition operable, with expectations for preserving key facial structures.
Select...
I had skin or cervical cancer before, but it was successfully treated.
Select...
I am not pregnant or breastfeeding.
Select...
I do not have severe numbness or pain in my hands or feet.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Structure preservation rate defined as both skull base and orbit being preserved

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
~6670
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Image Guided Radiation Therapy
2016
Completed Phase 2
~20
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,840 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,476 Total Patients Enrolled
Nabil SabaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03493425 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Arm A (surgery, IMRT, cisplatin, carboplatin), Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)
Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03493425 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03493425 — Phase 2
~39 spots leftby Mar 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top