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Phase 2

ChemotherapyChemotherapy 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

Sponsor:

ECOG-ACRIN Cancer Research Group

Code:

NCT03493425

Conditions

Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7

Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Cisplatin

Docetaxel

Image Guided Radiation Therapy

Intensity-Modulated Radiation Therapy

Study Details

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.

Conditions

Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7

Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7

Study ID

NCT03493425

Start date

Mar 12, 2019

Status verified date

Aug, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients must be >= 18 years of age
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have a general physical condition compatible with the proposed chemotherapy and surgery
Patients must have stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some patients with T4b disease deemed resectable by the treating surgeon can be included provided they fulfill all other eligibility criteria without involvement of the cavernous sinus
Patients with T4b who have the following characteristics leading to a T4b definition but who in the opinion of the treating surgeon can have resectable disease can be included provided they fulfill all other eligibility criteria and provided they have one of the following presentations: 1. Invasion of orbital apex without involvement of the cavernous sinus 2. Dura invasion depending on extent of involvement and if total resection is deemed feasible. 3. Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible. 4. Nasopharynx invasion if very limited 5. Clivus invasion if very limited. (Surgeons are encouraged to consult with the protocol surgical chair for these particular cases). Stages T3 and T4a and selected T4b 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 neoadjuvant chemotherapy for patients on Arm B using the score sheet provided at the end of the protocol.

Resection of skull base will be deemed necessary according to skull base bone erosion by computed tomography (CT) or marrow involvement by magnetic resonance imaging (MRI) is noted; for any disease abutting the skull base
Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging
Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization
Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
Absolute neutrophil count (ANC) > 1500/mm\^3 (=< 2 weeks prior to randomization)
Hemoglobin (Hgb) > 8.0 g/dL (=< 2 weeks prior to randomization)
Platelet count > 100,000/mm\^3 (=< 2 weeks prior to randomization)
For patients receiving cisplatin, creatinine clearance must be > 60 ml/min (=< 2 weeks prior to randomization); creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockcroft-Gault formula
Total bilirubin within 1.5 x the upper limit of normal (ULN) (must be obtained =< 2 weeks prior to randomization)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)
Alkaline phosphatase must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)
Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the chemotherapy and radiation being used; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy

All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achived menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not be expected conceive or father children by using an accepted and effective method(s) of contraception or by abstain from sexual intercourse for the duration of their participation in the study
Patient must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to randomization

Exclusion Criteria:

Patients may not be receiving investigational agents at time of randomization, or at any time while on study and during the 4 weeks preceding randomization
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and/or both platinum-based chemotherapy agents are ineligible; patient must be able to receive at least one of the two proposed chemotherapy regimens
Patients with evidence of distant metastases or leptomeningeal disease (LMD) are ineligbile
Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are ineligbile
Patients with a history of a different malignancy are ineligible, unless the disease has not progressed for >= 2 years
Patient must not have current peripheral neuropathy > grade 2 at time of randomization
Patient must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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 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.

Interventions

Carboplatin

Given IV

Cisplatin

Given IV

Docetaxel

Given IV

Image Guided Radiation Therapy

Undergo image guided IMRT

Intensity-Modulated Radiation Therapy

Undergo image guided IMRT

Laboratory Biomarker Analysis

Correlative studies

Questionnaire Administration

Ancillary studies

Therapeutic Conventional Surgery

Undergo standard of care surgery

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

ECOG-ACRIN Cancer Research Group

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group on 2026-08-19.