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Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
Overall Recruitment Status: Enrollment not started
 
Official Title
Randomized Phase II/III Trial of Radiation With High-Dose Cisplatin (100 mg/m2) Every Three Weeks Versus Radiation With Low-Dose Weekly Cisplatin (40 mg/m2) for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
 
Region Sponsors
Colorado
NRG Oncology
 
Acronym KP IRB No.
1933753
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Male and Female with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN)
 
Purpose
Phase II: *To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Phase III: *To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with highdose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. *To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN.
 
Detailed Description
Study Overview This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, 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 thereapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer. Patient/Provider Responsibilities Participants will either get radiation for 7 weeks and high-dose cisplatin every 3 weeks for up to 7 weeks, or they will get radiation for 7 weeks and low-dose cisplatin weekly for up to 7 weeks. After the participants finish treatment, their doctor will continue to follow their condition and monitor for side effects. Their doctor will check them 1 month after treatment and every 3 months for 2 years after treatment. After that, they will check participants every 6 months for 3 years, then annually. Primary Objectives Phase II: *To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Phase III: *To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with highdose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. *To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN. Secondary Objectives *To assess and compare progression-free survival (PFS) between arms. *To assess and compare locoregional failure and distant metastasis between arms. *To assess acute and late toxicity (CTCAE v5.0). *To assess patient-reported outcomes quality of life (PRO/QOL), as measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (primary PRO), between arms. *To assess hearing loss, as measured by audiograms and the modified TUNE grading scale between arms. *To assess hearing loss, as measured by speech audiometry Consonant-Nucleus-Consonant word scores and tympanometry (subject to the modified TUNE grading scale testing results; otherwise, it will be an exploratory objective). *To assess hearing-related QOL as measured by the Hearing Handicap Inventory-Screening (HHIA-S) (secondary PRO), between arms. Exploratory Objectives *To collect blood and tissue specimens for future translational science studies. For instance, to examine how germline and somatic genetic variants, such as TP53, CDKN2A, PIK3CA, PTEN, NFE2L2, and KEAP1, may influence cisplatin-related efficacy and toxicity, and to assess the effect of regular nonsteroidal antiinflammatory drugs (NSAIDs) use and genomic activation of PIK3CA (mutation or amplification) or loss of PTEN, the negative regulator of PI3K, on disease-free survival or overall survival.
 
Gender Age Limit
Male & Female 18 years & older
 
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
  • Please contact study team for additional inclusion criteria
 
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
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • 1,2-diaminocyclohexaneplatinum II citrate
  • Neoplasms by Histologic Type
  • Antineoplastic Agents
  • Neoplasms by Site
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Cisplatin
  • Squamous Cell Carcinoma of Head and Neck
  • Head and Neck Neoplasms
  • Oncology (Adult)
  • Neoplasms
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alexander Menter, MD
Contact Information:
- Alle Rutebemberwa, PhD
-alle.rutebemberwa@kp.org
-Franklin Medical Offices - Denver


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