Moffitt Cancer Center: Clinical Trial 19819

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Clinical Trial 19819

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03493425

Phase: Phase II
Prinicipal Investigator: Chung, Christine

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Overview

Study Title

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

Summary

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.

Objective

Primary Objectives: Evaluate the structure preservation rate for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care. Secondary Objectives: Evaluate progression-free survival (PFS) for this patient population. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration). Evaluate site reported p16 data and correlate with outcome. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of orbit and skull base preservation. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. Exploratory Tobacco Use Objectives: To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events (both clinical and hematologic) and dose modifications). To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit. NOTE: Tobacco Use objectives described above are ancillary for the Tobacco Use Assessment project approved by NCI. A combined analysis of the data from the selected ECOG-ACRIN trials is planned. Data collected from the tobacco use assessment in each parent study will not be analyzed and reported in the clinical study report.

Treatments

Therapies

Radiotherapy; Surgery; Therapy (NOS)

Medications

Paraplatin (carboplatin); Taxotere (docetaxel); carboplatin (); cisplatin (); docetaxel ()

Inclusion Criteria

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

General physical condition compatible with the proposed chemotherapy and surgery

Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: 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. (Some patients with T4b disease deemed resectable by the treating physician 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 andprovided they have one of the presentations identified in protocol.

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

Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base; or for ethmoid sinus or frontal sinus involvement

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

Adequate bone marrow function as determined by lab values as defined in protocol. Labs must be obtained 14 days or less prior to protocol randomization.

Adequate organ function per protocol

Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated

Patients 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

No current peripheral neuropathy > grade 2 at time of randomization

Women must not be pregnant or breast-feeding

All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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)

Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

Patients must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to registration

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 ineligible

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

Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are ineligible

Patients with a history of a different malignancy are excluded, unless the disease has not progressed for >= 2 years

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