Radiotherapy + Cisplatin for Oropharyngeal Cancer
(REDUCE-30 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for HPV-positive oropharyngeal cancer, a type of throat cancer. It combines radiotherapy with cisplatin, a chemotherapy drug, to determine if a lower radiation dose remains effective. The aim is to reduce side effects while effectively targeting the cancer. Individuals diagnosed with this specific throat cancer, without metastasis, may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that combining cisplatin with radiotherapy can cause common side effects. About 26.6% of patients experienced mouth sores, while 16.1% reported nausea and vomiting. A drop in white blood cells, increasing infection risk, occurred in 7.7% of patients.
Another study found that using weekly cisplatin with radiation is generally safe. Patients experienced some side effects, but proper care made them manageable. The combination treatment also showed promising results in fighting cancer.
Overall, despite side effects, many patients tolerate cisplatin with radiotherapy well. Always consult a healthcare professional about any concerns or questions regarding treatment options.12345Why are researchers excited about this trial's treatments for oropharyngeal cancer?
Most treatments for oropharyngeal cancer typically involve high doses of radiotherapy combined with chemotherapy drugs like Cisplatin. However, this new approach is unique because it explores reducing the radiation dose to just 30 Gy for the primary tumor and nodal areas. Researchers are excited because lowering the radiation dose could potentially minimize side effects while still effectively targeting the cancer. This could lead to a better quality of life for patients while maintaining the treatment's effectiveness.
What evidence suggests that radiotherapy and cisplatin might be an effective treatment for oropharyngeal cancer?
Research has shown that combining cisplatin, a chemotherapy drug, with radiotherapy effectively treats HPV-related throat cancer. Studies have found high survival rates among patients receiving this combination. For example, one study found that 81% of patients were alive after 2 years, and 63.5% were alive after 5 years, with nearly 90% achieving a complete response to the treatment. In this trial, participants will receive a reduced elective nodal and CTV dose of radiotherapy combined with cisplatin. Another study demonstrated that a lower dose of radiation with cisplatin resulted in 81.7% of patients surviving at 3 years and 70.7% at 5 years. These findings suggest that cisplatin with radiotherapy is a promising treatment option for this type of cancer.23678
Are You a Good Fit for This Trial?
This trial is for adults (18+) with HPV-positive oropharyngeal squamous cell carcinoma who are healthy enough for standard cisplatin treatment, have measurable disease on recent scans, and agree to use birth control. Participants must be able to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants receive a reduced dose of 30 Gy radiation to regions without visible cancer while maintaining standard dose to visible cancer, alongside standard systemic therapy of cisplatin
Follow-up
Participants are monitored for safety and effectiveness, including quality of life assessments and adverse event collection
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Radiotherapy
Trial Overview
The study tests if lowering the radiation dose to certain lymph nodes and tumor areas, along with standard cisplatin chemotherapy, is safe and effective in people with HPV-related throat cancer. All participants receive the same treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Reduction in primary tumor and nodal CTV dose to 30 Gy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sara Medek
Lead Sponsor
Citations
A prospective randomized study comparing concurrent ... - PMC
This study was conducted in a regional cancer center between August 2011 and September 2013 to compare the response and outcome of two different cisplatin ...
Reduced-Dose Radiation with Cisplatin Improves ...
2-year overall survival rates were 96.7% and 97.3% for the IMRT+C and the IMRT alone arms, respectively. While more grade 3-4 acute toxicities ...
Efficacy and safety of definitive low-dose weekly cisplatin ...
The 2- and 5-year overall survival (OS) rates were 81.0% and 63.5%, respectively, with a complete response rate of 89.7%. A cumulative cisplatin dose of ≥200 mg ...
4.
journals.lww.com
journals.lww.com/amjclinicaloncology/fulltext/2001/02000/concurrent_chemoradiotherapy_for_oropharyngeal.13.aspxConcurrent Chemoradiotherapy for Oropharyngeal ...
The 3-year CSS rate was 83% for patients treated with concurrent chemoradiotherapy using weekly cisplatin at least 3 times, whereas that was 53% for the ...
Radiotherapy plus cisplatin or cetuximab in low-risk human ...
Our data suggest that cisplatin-based chemoradiotherapy delivers substantially improved outcomes compared with bioradiotherapy with cetuximab, even in patients ...
Retrospective study of cisplatin plus radiotherapy toxicities in ...
The most common AEs related to cisplatin during RT were oral mucositis (26.6%, n= 159), nausea and vomiting (16.1%, n= 97), and neutropenia (7.7 ...
7.
ecancer.org
ecancer.org/en/news/19552-reduced-dose-rt-with-cisplatin-improves-outcomes-for-hpv-associated-oropharyngeal-carcinomaReduced-dose RT with cisplatin improves outcomes for ...
Data indicated that the IMRT C arm yielded a 2-year PFS rate of 90.5% (p=0.04, rejecting the null hypothesis of 2-year PFS ? 85%) compared to ...
Survival outcomes in patients with oropharyngeal cancer ...
Phase II trials have demonstrated 2-year overall survival of 66.6 % for stage III/IV resectable oro/hypopharyngeal treated with cisplatin, ...
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