Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive,… (NCT04106362) | Clinical Trial Compass
TerminatedPhase 2
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma
Stopped: low enrollment
United States1 participantsStarted 2020-01-14
Plain-language summary
This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, 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. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation
* Newly diagnosed, untreated, biopsy-proven HPV+ squamous cell carcinoma of the oropharynx. Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation and should be sufficient to estimate the size of the primary (for T stage). HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry
* Selective stage III-IV disease (T3-T4 or N2-N3 disease) by American Joint Committee on Cancer (AJCC) 8th edition as determined by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head and neck, CT neck, chest, abdomen, pelvis or a PET =\< 6 weeks of registration
* Confirmation of KRAS-variant status as assessed by genotyping from a cheek swab sample at MiraDx
* Lifetime cumulative smoking history of \< 10 pack-years. The cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
* Note: Investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone given that the effect of non-cigarette tobacco products on the survival of patients wi…
What they're measuring
1
Overall survival (OS)
Timeframe: From time of randomization to death due to any cause, assessed at 2 years