Lattice Radiotherapy + Chemo-Immunotherapy for Oral Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for oral cancer. Researchers aim to determine if lattice radiotherapy (a special type of radiation) combined with chemo-immunotherapy (a mix of chemotherapy and immunotherapy) is safe and effective. The trial consists of two parts: the first identifies the optimal dose, and the second tests that dose on more participants. It suits individuals with a confirmed diagnosis of non-metastatic oral cavity squamous cell carcinoma that can be surgically removed and who have not undergone certain treatments before. Participants should be able to tolerate surgery and have no severe health issues that could interfere with the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
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 Lattice Radiotherapy (LRT) is generally easy for patients to handle. In studies, over 80% of patients experienced tumor shrinkage and symptom improvement. One study found that LRT was safe and effective for individuals with large tumors, suggesting it as a promising treatment with manageable side effects.
Chemotherapy, however, often causes side effects like mouth sores, dry mouth, and changes in taste. A study found that serious side effects occurred in about 17.5% of patients. This indicates that while most patients handle chemotherapy fairly well, some face a risk of more serious issues.
Overall, both treatments have demonstrated relative safety for many patients, but awareness of possible side effects remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Lattice Radiotherapy (LRT) combined with chemo-immunotherapy for oral cancer because it offers a new approach to delivering radiation. Unlike traditional radiotherapy, which targets the entire tumor uniformly, LRT delivers high-dose radiation in a grid-like pattern, potentially sparing healthy tissue and reducing side effects. This method could enhance the effectiveness of chemotherapy and immunotherapy by creating a more targeted treatment environment. Additionally, the innovative combination aims to improve patient outcomes by harnessing the body's immune response alongside direct cancer cell destruction.
What evidence suggests that this trial's treatments could be effective for oral cancer?
Research shows that lattice radiotherapy (LRT), one of the treatments studied in this trial, may help treat large tumors by protecting healthy tissues, which is beneficial for oral cancer treatment. Some studies have found LRT to be effective and well-tolerated, even for large tumors. In this trial, participants will also receive chemotherapy, which may include drugs like carboplatin and 5-FU. These drugs can shrink oral cavity tumors but might cause more side effects. Previous research indicates that administering chemotherapy before the main treatment, known as neoadjuvant chemotherapy, has improved survival rates for patients with advanced oral cancer. These treatments suggest they could effectively manage oral cancer, especially if surgery is an option later.678910
Who Is on the Research Team?
Colin Hill, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adults with non-metastatic, resectable oral cavity squamous cell carcinoma. Participants must have a good performance status, adequate kidney function, and tumors or lymph nodes ≥3 cm. Men and women of childbearing potential must agree to use contraception. Exclusion criteria are not specified but typically include factors that could affect safety or results.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding
Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3 to identify the maximum tolerated dose (MTD)
Expansion
Additional enrolment at the selected maximum tolerated dose (MTD) with chemo-immunotherapy
Surgery and Adjuvant Therapy
Surgery occurs 6-8 weeks after radiotherapy; adjuvant therapy is pathology-driven
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chemotherapy
- Lattice Radiotherapy (LRT)
Trial Overview
The study tests Lattice Radiotherapy (LRT) combined with chemotherapy in two parts: dose-finding to determine the safest radiation dose and expansion at this dose for more patients. The treatment targets either just the primary tumor or both the tumor and involved nodes, followed by surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All Part 2 subjects receive the MTD together with chemo-immunotherapy.
Treatment starts at dose level 2 (9 Gy × 3 lattice fractions). A single "sentinel" patient is treated first; if no dose-limiting toxicity (DLT) occurs, the trial continues in fixed three-patient cohorts. The Bayesian Optimal Interval (BOIN) algorithm, set to a target DLT rate of 20%, governs escalation or de-escalation among the three prespecified dose levels (8, 9 and 10 Gy × 3). The principal objective of Part 1 is to identify the maximum tolerated dose (MTD).
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
Systematic Review of the Literature and Meta-Analysis - PMC
Oral cavity carcinoma (OCC) is listed as the 11th most frequently diagnosed cancer (2.0% of all cancers) [1] and as the 15th most frequently deadly cancer, ...
10-year outcomes of technically unresectable oral cancers ...
The median OS was 9 months (95% CI: 8.6 – 9.4). NACT with more than 2-drugs had an OS of 13.2 months (95% CI: 12 – 14.4) vs 7.5 months (95% CI: ...
Chemotherapy for Oral Cavity and Oropharyngeal Cancer
Combining drugs can often shrink tumors better, but tend to cause more side effects. A commonly used combination is carboplatin and 5-FU. This ...
Retrospective analysis of clinical outcome of 100 ...
Inoperable patients of OC-SCC treated with definitive CTRT with or without IC yielded CR in approximately half of patients with acceptable toxicity profiles.
5.
acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21829Neoadjuvant chemotherapy for advanced oral cavity cancer
Patients who had at least a partial response had improved 5-year OS (60%) and disease-specific survival (79%) compared with those who did not ...
The Impact of Preventive Protocols on Oral Health Outcomes ...
Background/Objectives: Cancer patients undergoing chemotherapy (CT) or radiotherapy (RT) are at increased risk of oral complications.
7.
jhoponline.com
jhoponline.com/issue-archive/2023-issues/april-2023-vol-13-no-2/oral-chemotherapy-program-metrics-results-of-a-national-surveyOral Chemotherapy Program Metrics: Results of a National ...
The most frequently collected safety outcomes were drug-related problems detected and addressed by pharmacists (68%), follow-up interventions ...
Oral chemotherapy safety practices at US cancer centres
Our data indicate that prescribing, monitoring and coordination, pharmacy practices, and education of patients for oral chemotherapy vary substantially. Despite ...
Patient-reported oral adverse events during cancer ...
Oral adverse events (AEs), such as mucositis, dry mouth, hoarseness, and taste changes, are common complications during cancer chemotherapy that ...
Efficacy and safety of triple oral metronomic chemotherapy ...
Grade 3 toxicity was seen in 17.5% (n = 10) patients. Median follow-up of the cohort was 28.8 months (95%CI, 18.7-39.1). The median PFS and OS ...
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