NCT03493425|Active Not RecruitingPhase 2DMCFDA Drug

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

Phase II Randomized Trial of Neoadjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a (and Selected T4b) Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

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3 other identifiers

EA3163NCI-2017-01364U10CA180820

Study Type

interventional

Target

Locations

1 country

Sites

154

Timeline

RegisteredApr 2018

StartedMar 2019

CompletionMar 2029

Brief Summary

This 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. Chemotherapy drugs, 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

30mo left

Started Mar 2019

Longer than P75 for phase_2

Geographic Reach

1 country

154 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.1 years study duration

Study Progress75%

Mar 2019Mar 2029

First Submitted

Initial submission to the registry

January 26, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed

11 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed

10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

10.1 years

First QC Date

January 26, 2018

Last Update Submit

September 10, 2026

Conditions

Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7 Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7

Outcome Measures

Primary Outcomes (2)

Structure preservation rate defined as both skull base and orbit being preserved
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).
Up to 5 years
Overall survival (OS)
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).
From date of randomization, censoring follow-up at last date of contact, assessed for up to 5 years

Secondary Outcomes (2)

Change in accuracy of magnetic resonance imaging (MRI) and fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT) to predict orbital and skull base preservation
Baseline and post-chemotherapy
OS by imaging biomarkers
From date of randomization, censoring follow-up at last date of contact, assessed at 2 years

Study Arms (2)

Arm A (surgery, IMRT, cisplatin, carboplatin)

ACTIVE COMPARATOR

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.

Drug: CarboplatinDrug: CisplatinRadiation: Image Guided Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Questionnaire AdministrationProcedure: Therapeutic Conventional Surgery

Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)

EXPERIMENTAL

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 cycles 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.

Drug: CarboplatinDrug: CisplatinDrug: DocetaxelRadiation: Image Guided Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Questionnaire AdministrationProcedure: Therapeutic Conventional Surgery

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo