Clinical Trial - NCT03493425

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

Recruiting

Sponsor: ECOG-ACRIN Cancer Research Group

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03493425

Protocol Info

Short Description: Phase II Surgery + Radiation +/- Neo-Adjuvant Chemo in NPNSCC
Long Description: 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)
MGH Status: Open
Sponsor: Coop/ECOG
Disease Program: Head & Neck

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7 Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7 Carboplatin Cisplatin Docetaxel Image Guided Radiation Therapy Intensity-Modulated Radiation Therapy Laboratory Biomarker Analysis Questionnaire Administration Therapeutic Conventional Surgery Phase 2
Study Type Interventional
Official 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)

Primary Outcome Measures

Structure preservation rate defined as both skull base and orbit being preserved [Time Frame: Up to 5 years] [Designated as safety issue: ]

Overall survival (OS) [Time Frame: From date of randomization, censoring follow-up at last date of contact, assessed for up to 5 years] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 134
Study Start Date: March 2018
Estimated Study Completion Date: February 2028
Estimated Primary Completion Date: February 2023
Arms Assigned Interventions

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.
Procedure:Therapeutic Conventional Surgery
Undergo standard of care surgery

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 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.
Drug:Docetaxel
Given IV

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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
  • 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
  • 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 at least one of the two proposed chemotherapy regimens
  • 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03493425

Locations

  • United States, Arizona
    • University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona, United States, 85704
    • Banner University Medical Center - Tucson Tucson, Arizona, United States, 85719
    • University of Arizona Cancer Center-North Campus Tucson, Arizona, United States, 85719
  • United States, Arkansas
    • Mercy Hospital Fort Smith Fort Smith, Arkansas, United States, 72903
  • United States, California
    • UC San Diego Moores Cancer Center La Jolla, California, United States, 92093
    • VA Palo Alto Health Care System Palo Alto, California, United States, 94304
  • United States, Connecticut
    • Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut, United States, 06510
    • Yale University New Haven, Connecticut, United States, 06520
  • United States, Florida
    • UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida, United States, 33146
    • UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida, United States, 33442
    • University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida, United States, 33136
    • Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Georgia
    • Emory Proton Therapy Center Atlanta, Georgia, United States, 30308
    • Emory University Hospital Midtown Atlanta, Georgia, United States, 30308
    • Emory University Hospital/Winship Cancer Institute Atlanta, Georgia, United States, 30322
  • United States, Idaho
    • Saint Alphonsus Cancer Care Center-Boise Boise, Idaho, United States, 83706
    • Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho, United States, 83605
    • Kootenai Medical Center Coeur d'Alene, Idaho, United States, 83814
    • Idaho Urologic Institute-Meridian Meridian, Idaho, United States, 83642
    • Saint Alphonsus Medical Center-Nampa Nampa, Idaho, United States, 83686
    • Kootenai Cancer Center Post Falls, Idaho, United States, 83854
  • United States, Illinois
    • Rush - Copley Medical Center Aurora, Illinois, United States, 60504
    • Northwestern University Chicago, Illinois, United States, 60611
    • Carle on Vermilion Danville, Illinois, United States, 61832
    • Carle Physician Group-Effingham Effingham, Illinois, United States, 62401
    • NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois, United States, 60201
    • NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois, United States, 60026
    • NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois, United States, 60035
    • Carle Physician Group-Mattoon/Charleston Mattoon, Illinois, United States, 61938
    • Good Samaritan Regional Health Center Mount Vernon, Illinois, United States, 62864
    • Carle Cancer Center Urbana, Illinois, United States, 61801
    • The Carle Foundation Hospital Urbana, Illinois, United States, 61801
  • United States, Iowa
    • Iowa Methodist Medical Center Des Moines, Iowa, United States, 50309
    • Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa, United States, 50309
    • Broadlawns Medical Center Des Moines, Iowa, United States, 50314
    • Iowa Lutheran Hospital Des Moines, Iowa, United States, 50316
    • Methodist West Hospital West Des Moines, Iowa, United States, 50266-7700
  • United States, Kansas
    • University of Kansas Cancer Center Kansas City, Kansas, United States, 66160
    • Olathe Health Cancer Center Olathe, Kansas, United States, 66061
    • University of Kansas Cancer Center-Overland Park Overland Park, Kansas, United States, 66210
    • Ascension Via Christi - Pittsburg Pittsburg, Kansas, United States, 66762
    • Salina Regional Health Center Salina, Kansas, United States, 67401
    • University of Kansas Health System Saint Francis Campus Topeka, Kansas, United States, 66606
    • University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas, United States, 66205
  • United States, Kentucky
    • The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky, United States, 40202
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
    • Henry Ford Cancer Institute-Downriver Brownstown, Michigan, United States, 48183
    • Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan, United States, 48038
    • Wayne State University/Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Henry Ford Hospital Detroit, Michigan, United States, 48202
    • Weisberg Cancer Treatment Center Farmington Hills, Michigan, United States, 48334
    • Allegiance Health Jackson, Michigan, United States, 49201
    • Henry Ford Macomb Health Center - Shelby Township Shelby, Michigan, United States, 48315
    • Henry Ford West Bloomfield Hospital West Bloomfield, Michigan, United States, 48322
  • United States, Minnesota
    • Sanford Joe Lueken Cancer Center Bemidji, Minnesota, United States, 56601
  • United States, Missouri
    • Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri, United States, 63011
    • Siteman Cancer Center at West County Hospital Creve Coeur, Missouri, United States, 63141
    • Freeman Health System Joplin, Missouri, United States, 64804
    • Mercy Hospital Joplin Joplin, Missouri, United States, 64804
    • University of Kansas Cancer Center - North Kansas City, Missouri, United States, 64154
    • University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri, United States, 64116
    • Delbert Day Cancer Institute at PCRMC Rolla, Missouri, United States, 65401
    • Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri, United States, 65401
    • Heartland Regional Medical Center Saint Joseph, Missouri, United States, 64506
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Mercy Hospital South Saint Louis, Missouri, United States, 63128
    • Siteman Cancer Center-South County Saint Louis, Missouri, United States, 63129
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
    • Siteman Cancer Center at Saint Peters Hospital Saint Peters, Missouri, United States, 63376
    • Mercy Hospital Springfield Springfield, Missouri, United States, 65804
    • CoxHealth South Hospital Springfield, Missouri, United States, 65807
  • United States, Montana
    • Billings Clinic Cancer Center Billings, Montana, United States, 59101
    • Bozeman Deaconess Hospital Bozeman, Montana, United States, 59715
    • Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana, United States, 59405
    • Great Falls Clinic Great Falls, Montana, United States, 59405
    • Kalispell Regional Medical Center Kalispell, Montana, United States, 59901
    • Community Medical Hospital Missoula, Montana, United States, 59804
  • United States, New York
    • Northwell Health Imbert Cancer Center Bay Shore, New York, United States, 11706
    • Montefiore Medical Center-Einstein Campus Bronx, New York, United States, 10461
    • Montefiore Medical Center-Weiler Hospital Bronx, New York, United States, 10461
    • Montefiore Medical Center - Moses Campus Bronx, New York, United States, 10467
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Northwell Health/Center for Advanced Medicine Lake Success, New York, United States, 11042
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, North Carolina
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
  • United States, North Dakota
    • Sanford Bismarck Medical Center Bismarck, North Dakota, United States, 58501
    • Sanford Broadway Medical Center Fargo, North Dakota, United States, 58122
    • Sanford Roger Maris Cancer Center Fargo, North Dakota, United States, 58122
  • United States, Ohio
    • University of Cincinnati/Barrett Cancer Center Cincinnati, Ohio, United States, 45219
    • University Pointe West Chester, Ohio, United States, 45069
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
    • Mercy Hospital Oklahoma City Oklahoma City, Oklahoma, United States, 73120
  • United States, Pennsylvania
    • UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania, United States, 15009
    • UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania, United States, 15601
    • UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania, United States, 17109
    • Thomas Jefferson University Hospital Philadelphia, Pennsylvania, United States, 19107
    • University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania, United States, 15232
    • UPMC-Shadyside Hospital Pittsburgh, Pennsylvania, United States, 15232
    • UPMC-Passavant Hospital Pittsburgh, Pennsylvania, United States, 15237
    • UPMC Washington Hospital Radiation Oncology Washington, Pennsylvania, United States, 15301
  • United States, South Dakota
    • Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota, United States, 57104
    • Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota, United States, 57117-5134
  • United States, Texas
    • Parkland Memorial Hospital Dallas, Texas, United States, 75235
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas, United States, 75080
  • United States, Wisconsin
    • Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin, United States, 54701
    • Marshfield Medical Center-Marshfield Marshfield, Wisconsin, United States, 54449
    • Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
    • Marshfield Clinic-Minocqua Center Minocqua, Wisconsin, United States, 54548
    • Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin, United States, 54868
    • Marshfield Clinic Stevens Point Center Stevens Point, Wisconsin, United States, 54482
    • Marshfield Clinic-Wausau Center Wausau, Wisconsin, United States, 54401
    • Diagnostic and Treatment Center Weston, Wisconsin, United States, 54476
    • Marshfield Clinic - Weston Center Weston, Wisconsin, United States, 54476
  • United States, Wyoming
    • Welch Cancer Center Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

ECOG-ACRIN Cancer Research Group

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03493425
Other Study ID Numbers: NCI-2017-01364
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Cisplatin

Carboplatin

Docetaxel

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on October 14, 2020