Chemotherapy and Radiation Based on EBV DNA for Nasopharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether different chemotherapy treatments, combined with radiation, can more effectively treat nasopharyngeal cancer, which occurs in the upper part of the throat behind the nose. After initial chemotherapy and radiation, the trial checks for a virus-related DNA marker (EBV DNA) in the blood to decide the next step: additional chemotherapy or observation. Participants must have nasopharyngeal cancer with this viral marker detectable in their blood before starting the trial. The trial aims to determine which post-radiation treatment best combats cancer cells. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, a complete list of your current medications will be assessed during the eligibility evaluation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial have been used before, providing valuable safety information.
Studies have shown that the combination of cisplatin and fluorouracil is a common chemotherapy treatment. It is generally well-tolerated, though some patients may experience side effects like nausea or low blood counts, which are often manageable with supportive care.
Past research has also demonstrated the effectiveness of the gemcitabine and paclitaxel combination. Some patients might experience side effects such as tiredness or low blood counts, which are usually manageable with care.
Both treatment options have been used previously, giving doctors insight into their safety. They are not new drugs, so more is known about their effects on the body. However, individual reactions can vary. Always discuss any concerns with your doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for nasopharyngeal cancer because they uniquely tailor chemoradiation based on Epstein-Barr virus (EBV) DNA levels, potentially enhancing precision in treatment. The study includes different arms with distinct combinations of drugs like cisplatin and fluorouracil, or gemcitabine hydrochloride and paclitaxel, each offering alternative approaches to attacking the cancer cells. These combinations aim to optimize effectiveness and minimize side effects compared to traditional chemotherapy regimens alone. By incorporating intensity-modulated radiation therapy (IMRT), the approach also focuses on delivering targeted radiation, reducing damage to surrounding healthy tissue. This personalized strategy could lead to better outcomes and fewer side effects for patients.
What evidence suggests that this trial's treatments could be effective for nasopharyngeal cancer?
Research has shown that using gemcitabine and paclitaxel together can help treat certain cancers. In some studies, this combination worked for many patients, with a success rate of 55% to 75%. Patients in these studies lived for an average of 10 to 12 months, which is promising for advanced cases. Both gemcitabine and paclitaxel stop cancer cells from growing and spreading. This trial will evaluate the effectiveness of the gemcitabine and paclitaxel combination for nasopharyngeal cancer in one of the treatment arms. While it's not yet clear if this combination is better than other treatments for nasopharyngeal cancer, early results suggest it could help manage the disease.36789
Who Is on the Research Team?
Nancy Lee
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for patients with Stage II-IVB nasopharyngeal cancer without distant metastasis. They must have detectable EBV DNA in their plasma, adequate organ function, and agree to use birth control if applicable. Exclusions include major illness affecting trial participation, recent heart issues or infections requiring IV antibiotics, prior malignancies within 3 years (except certain skin cancers), previous chemotherapy or radiotherapy for the study cancer, severe neuropathy, AIDS, and significant co-morbidities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants undergo intensity modulated radiation therapy (IMRT) once daily 5 days a week for 6.5 weeks and receive low-dose cisplatin intravenously once weekly during IMRT.
EBV DNA Analysis
Plasma samples are collected for EBV DNA analysis 1 week after chemoradiation.
Adjuvant Treatment
Based on EBV DNA results, patients receive either PF regimen (cisplatin and fluorouracil) or GT regimen (gemcitabine and paclitaxel) or undergo observation.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Fluorouracil
- Gemcitabine Hydrochloride
- Intensity-Modulated Radiation Therapy
- Paclitaxel
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