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New treatment option for Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma...
Official title 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
ClinicalTrials.gov ID: NCT03493425
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for stage iii nasal cavity and paranasal sinus squamous cell carcinoma ajcc v6 and v7.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- Patients may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding enrollment
- 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 excluded; patient must be able to receive...
- 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
- Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded
- Patients with a history of a different malignancy are excluded, unless the disease has not progressed for \>= 2 years
- 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
- Creatinine clearance of \> 60 ml/min; creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula =\< 2 weeks prior to randomization
- Total bilirubin within normal limits (must be obtained =\< 2 weeks prior to randomization)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained \< 2 weeks prior to randomization
- Alkaline phosphatase must be within the range 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
- No current peripheral neuropathy \> grade 2 at time of randomization
- 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
- 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...
- 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...
- Patients must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to registration
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- New Haven, Connecticut, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Post Falls, Idaho, United States
- Aurora, Illinois, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
+ 86 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Fort Smith, Arkansas, United States; La Jolla, California, United States; Palo Alto, California, United States; New Haven, Connecticut, United States; Coral Gables, Florida, United States and 100 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.