IMRT +/− Cisplatin for Oropharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of intensity-modulated radiation therapy (IMRT), both alone and combined with the chemotherapy drug cisplatin, in treating advanced oropharyngeal cancer (throat cancer). Researchers aim to determine which method more effectively stops the cancer from growing and spreading. Individuals diagnosed with specific types of throat cancer and a smoking history of 10 pack-years or less may qualify. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intensity-modulated radiation therapy (IMRT) is generally safe and well-tolerated. Studies have found that IMRT effectively targets tumors while minimizing exposure to nearby healthy tissues, reducing the risk of damage to those areas.
Adding the chemotherapy drug cisplatin to IMRT may cause some side effects. Common issues include painful mouth sores, nausea, vomiting, and low white blood cell counts. Despite these side effects, cisplatin is widely used and has proven effective in treating various cancers.
Since this trial is in an early phase, researchers are still testing the treatments for safety, but previous data reassures many patients. Always consult a healthcare provider about potential side effects to understand what to expect and how to manage them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for oropharyngeal cancer because they combine Intensity-Modulated Radiation Therapy (IMRT) with and without cisplatin in innovative ways. IMRT is a precise radiation technique that targets cancer cells while sparing healthy tissue, potentially reducing side effects compared to traditional radiation methods. When combined with cisplatin, a chemotherapy drug, there is a possibility of boosting the cancer-killing effects of radiation. This dual approach aims to enhance the effectiveness of treatment, offering hope for improved outcomes and quality of life for patients compared to the standard treatment options, which typically involve surgery, conventional radiation, and chemotherapy.
What evidence suggests that this trial's treatments could be effective for oropharyngeal cancer?
Research has shown that intensity-modulated radiation therapy (IMRT) can effectively treat oropharyngeal cancer, which affects the throat. Studies indicate that 61.3% of patients treated with IMRT survive for at least five years. IMRT also reduces long-term side effects compared to older radiation methods.
In this trial, one group of participants will receive IMRT alone for 5 weeks, while another group will receive IMRT for 6 weeks combined with the chemotherapy drug cisplatin. Cisplatin enhances the effectiveness of radiation therapy and helps protect organs while extending survival in head and neck cancers. Research has shown that the three-year survival rate for patients treated with cisplatin and other chemotherapy is about 74.9%. These findings suggest that using both IMRT and cisplatin could be an effective approach for treating this type of cancer.12678Who Is on the Research Team?
Sue Yom
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with advanced oropharyngeal cancer, which includes cancers of the mouth and throat. Participants must have a specific type of squamous cell carcinoma confirmed by pathology, measurable disease, and positive p16 immunohistochemistry. They should be in good physical condition (Zubrod Performance Status 0-1), not exceed a 10 pack-year smoking history, and have proper organ function. HIV-positive patients can join if they meet certain health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intensity-modulated radiation therapy (IMRT) for 5 or 6 weeks, with or without concurrent cisplatin chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 3 months, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Intensity-Modulated Radiation Therapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator