Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Advanced Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration; specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site
- For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
P16 status based on local site immunohistochemical tissue staining is required. A cell block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable.
- The p16 results must be reported on the pathology report being submitted. The p16 positivity is defined as > 70% of tumor cells showing strong nuclear and/or cytoplasmic immunostaining with p16 antibody.
For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status is NOT required
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving =< 4 nodes are permitted and considered as non-therapeutic nodal excisions
- Clinical stage (American Joint Committee on Cancer [AJCC], 8th ed.), including no distant metastases based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration
- One of the following imaging studies is required within 60 days prior to registration:
- Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless contraindicated) OR
- Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) OR
Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT component should be of diagnostic quality with contrast, unless contraindicated.
Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes of radiation planning may serve as both staging and planning tools
- One of the following imaging studies is required within 60 days prior to registration:
- FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR
Chest CT
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;
Eligibility by patient cohort;
- Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging (AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
- Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3, or T3-4 N0-1
p16-positive OPC/CUP Cohort;
- Tumor Site: OPC; Smoking Status: =< 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1-3 N2-3 or T4 N0-3
- Tumor Site: OPC; Smoking Status: > 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1-2 N2-3 or T3-4 N0-3
Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
- Age >= 18
- Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14 days prior to registration
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration)
- Platelets >= 75,000 cells/mm^3 (within 30 days prior to registration)
Hemoglobin >= 8.0 g/dL (within 30 days prior to registration)
- Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
- Calculated creatinine clearance (CrCl) >= 50 mL/min by the Cockcroft-Gault formula (within 30 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 30 days prior to registration) (not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x institutional ULN (within 30 days prior to registration)
- Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell count > 200 cells/mm^3 are eligible for this trial. Testing is not required for entry into protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes
- Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 14 months (females); for 11 months (males) following last dose of cisplatin; this inclusion is necessary because the treatment in this study may be significantly teratogenic
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP)
- Recurrence of the study cancer
- Definitive clinical or radiologic evidence of distant metastatic disease
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity defined as follows:
- Unstable angina requiring hospitalization in the last 6 months
- Myocardial infarction within the last 6 months
- New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing
- Patient must not have an active infection requiring IV antibiotics prior to registration;
- Other chronic renal disease like nephrotic syndrome, that could be worsened by cisplatin therapy
- History of allogenic organ transplantation
- Any symptomatic peripheral sensory neuropathy grade >= 2 (CTCAE version 5.0);
- Pregnancy and individuals unwilling to discontinue nursing
Sites / Locations
- Mobile Infirmary Medical CenterRecruiting
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
- Tower Cancer Research FoundationRecruiting
- Kaiser Permanente DublinRecruiting
- UC San Diego Health System - Encinitas
- Kaiser Permanente-FremontRecruiting
- Fresno Cancer CenterRecruiting
- Kaiser Permanente-FresnoRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Palo Alto Medical Foundation-Camino DivisionRecruiting
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-OntarioRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Rohnert Park Cancer CenterRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Sutter Roseville Medical CenterRecruiting
- The Permanente Medical Group-Roseville Radiation OncologyRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- South Sacramento Cancer CenterRecruiting
- UC San Diego Medical Center - Hillcrest
- Kaiser Permanente-San FranciscoRecruiting
- UCSF Medical Center-Mount ZionRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Stanford Cancer Center South BayRecruiting
- Kaiser Permanente San LeandroRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- Kaiser Permanente Cancer Treatment CenterRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Kaiser Permanente-FranklinRecruiting
- Porter Adventist HospitalRecruiting
- SCL Health Saint Joseph HospitalRecruiting
- Kaiser Permanente-Rock CreekRecruiting
- Littleton Adventist HospitalRecruiting
- Kaiser Permanente-Lone TreeRecruiting
- Parker Adventist HospitalRecruiting
- George Washington University Medical CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at AventuraRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- Augusta University Medical CenterRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial Hospital
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Edward Hines Jr VA HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Edward Hospital/Cancer Center
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran HospitalRecruiting
- Methodist West HospitalRecruiting
- Mercy Medical Center-West LakesRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Jewish Hospital
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Louisiana State University Health Science CenterRecruiting
- University Medical Center New OrleansRecruiting
- MaineHealth Coastal Cancer Treatment CenterRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-BiddefordRecruiting
- Lafayette Family Cancer Center-EMMCRecruiting
- Maine Medical Center-Bramhall CampusRecruiting
- MaineHealth Cancer Care Center of York CountyRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-SanfordRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Maryland Proton Treatment CenterRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Central Maryland Radiation Oncology in Howard CountyRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- GenesisCare USA - ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- GenesisCare USA - Farmington HillsRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- GenesisCare USA - MacombRecruiting
- GenesisCare USA - Madison HeightsRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- 21st Century Oncology-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- GenesisCare USA - TroyRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Francis Medical CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Saint James Community Hospital and Cancer Treatment CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Glens Falls HospitalRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- FirstHealth of the Carolinas-Moore Regional HospitalRecruiting
- Novant Cancer Institute Radiation Oncology - SupplyRecruiting
- Wake Forest Baptist Health - Wilkes Medical CenterRecruiting
- Novant Health Cancer Institute Radiation Oncology - WilmingtonRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- Summa Health System - Barberton CampusRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- ProMedica Flower HospitalRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Bryn Mawr HospitalRecruiting
- Saint Vincent HospitalRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- Jefferson HospitalRecruiting
- Riddle Memorial HospitalRecruiting
- Forbes HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Temple University Hospital
- Allegheny General HospitalRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Lankenau Medical CenterRecruiting
- Medical University of South CarolinaRecruiting
- Self Regional HealthcareRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- Michael E DeBakey VA Medical Center
- Huntsman Cancer Institute/University of UtahRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Inova Schar Cancer InstituteRecruiting
- FHCC OverlakeRecruiting
- Seattle Cancer Care Alliance at EvergreenHealthRecruiting
- FHCC South Lake UnionRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- FHCC at Northwest HospitalRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- William S Middleton VA Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Medical College of WisconsinRecruiting
- Zablocki Veterans Administration Medical CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Drexel Town Square Health CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Ascension Saint Michael's HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- The Research Institute of the McGill University Health Centre (MUHC)Recruiting
- Allan Blair Cancer CentreRecruiting
- Saskatoon Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
ARM I (high-dose cisplatin, radiation therapy)
Arm II (low-dose cisplatin, radiation therapy)
Arm III (high-dose cisplatin, radiation therapy)
Arm IV (low-dose cisplatin, radiation therapy)
NON-OPC/p16-NEGATIVE OPC: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
NON-OPC/p16-NEGATIVE OPC: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV QW during radiation therapy in the absence of disease progression or unacceptable toxicity.
p16-POSITIVE OPC/CUP: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
p16-POSITIVE OPC/CUP: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV QW during radiation therapy in the absence of disease progression or unacceptable toxicity.