Induction Chemoimmunotherapy to Prevent Laryngectomy in Advanced Laryngeal Cancer and Hypopharyngeal Cancer

A vizsgálat adatai

Ki végzi

Mayo Clinic

Azonosító

NCT07923877

A regiszteradat frissítve

2026. november 9.

Eredeti leírás

This phase II trial tests the effect of early (induction) standard chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab in preventing more extensive surgery to remove the voice box (laryngectomy), in patients with laryngeal squamous cell cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or hypopharyngeal cancer of any stage. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Response to treatment with chemoimmunotherapy may help guide further treatment, such as radiation therapy with or without cisplatin. Intensity-modulated radiation therapy (IMRT) is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Intensity-modulated proton therapy is a type of proton beam radiation therapy that uses precise proton beams to target tumors while sparing the surrounding healthy tissue. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Giving induction chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab may be an effective strategy to prevent more invasive treatments, such as a laryngectomy, while improving both survival and quality of life in patients with advanced laryngeal squamous cell carcinoma and hypopharyngeal squamous cell carcinoma.A teljes eredeti leírásKevesebb

Induction Bio-Selection Organ Preservation for Advanced Laryngeal Cancer (IBOP)

This phase II trial tests the effect of early (induction) standard chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab in preventing more extensive surgery to remove the voice box (laryngectomy), in patients with laryngeal squamous cell cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or hypopharyngeal cancer of any stage. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Response to treatment with chemoimmunotherapy may help guide further treatment, such as radiation therapy with or without cisplatin. Intensity-modulated radiation therapy (IMRT) is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Intensity-modulated proton therapy is a type of proton beam radiation therapy that uses precise proton beams to target tumors while sparing the surrounding healthy tissue. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Giving induction chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab may be an effective strategy to prevent more invasive treatments, such as a laryngectomy, while improving both survival and quality of life in patients with advanced laryngeal squamous cell carcinoma and hypopharyngeal squamous cell carcinoma.

Bevonási feltételek: Age ≥ 18 years; Histological confirmation of squamous cell carcinoma of larynx or hypopharynx. Larynx squamous cell carcinoma is ≥ cT2N+ or cT3-4N any, or any hypopharynx cancer regardless of stage. Individuals with a new diagnosis or who were previously treated with endoscopic resections alone are eligible; Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2; Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only; Ability to complete questionnaire(s) by themselves or with assistance; Provide written informed consent; Willing to return to enrolling institution for follow-up (during the active monitoring and follow-up phase of the study); Willing to provide mandatory tissue and/or blood samples for correlative research purposes; Confirmation of no evidence of distant metastasis (M0 as defined in American Joint Committee on Cancer [AJCC] 8th edition) by PET/CT or PET.

Kizáró feltételek: Co-morbid systemic illnesses or other severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; Prior radiation to the head and neck area with exception of ≤ 30 Gy; Any patient who has concurrent illness that would make them ineligible for chemotherapy per medical oncology evaluation; Prior systemic treatment specifically for this larynx/hypopharynx cancer; Any contraindications to receiving immunotherapy such as active autoimmune disease, recent organ transplantation deemed too risky for immunotherapy use, or other medical conditions that would make the patient ineligible for immunotherapy as deemed per medical oncology; Uncontrolled intercurrent illness including, but not limited to:; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Or psychiatric illness/social situations that would limit compliance with study requirements; History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; Any malignancy for which the treatment may interfere with ability to deliver treatment paradigm on trial; Any of the following:; Pregnant persons; Nursing persons; Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception.

ClinicalTrials.gov NCT07923877