癌研連線CancerLink
暂停 NCT05050162

比较每三周一次cisplatin与每周一次cisplatin结合放射治疗用于晚期头颈癌患者

头颈癌皮肤癌Phase IIIII 期IV 期

此第二/三期试验比较每周给予cisplatin结合放射治疗与每三周给予cisplatin结合放射治疗，用于治疗已扩散至身体其他部位（晚期）的头颈癌，何者耐受性较佳。

适应症：Advanced Head and Neck Squamous Cell Carcinoma、Advanced Hypopharyngeal Squamous Cell Carcinoma、Advanced Laryngeal Squamous Cell Carcinoma、Advanced Oropharyngeal Squamous Cell Carcinoma、Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8、Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8、Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8、Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8、Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8、Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

入组条件

纳入标准

  • 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 must 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.): T1N2-3, T2N1-3, or T3-4 N0-3
  • Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3 Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation.
  • 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)

排除标准

  • 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
  • History of hypersensitivity to cisplatin or platinum-containing compounds

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。