Lattice Radiotherapy + Chemoimmunotherapy for Squamous Cell Carcinoma

KH
FH
Overseen ByFraustina Hsu
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of chemoimmunotherapy (a treatment combining chemotherapy and immunotherapy) and a specialized radiotherapy called lattice radiotherapy for treating squamous cell carcinoma, a type of throat cancer. The researchers aim to determine the optimal dose patients can tolerate while assessing the treatment's ability to shrink tumors. Individuals with a primary or lymph node tumor in the throat measuring at least 3 cm and a significant smoking history may qualify for this trial. As a Phase 1/Phase 2 trial, the research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking cancer treatment advancements.

Do I need to stop my current medications for the trial?

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?

Previous studies have demonstrated the safety of induction chemoimmunotherapy. One study found no treatment-related deaths and reported promising results in slowing disease progression. Most patients tolerated the treatment well, with few experiencing severe side effects.

Research on lattice radiotherapy (LRT) suggests it is a safe and effective option, particularly for large tumors. Studies have shown that LRT significantly reduces tumor size and is well-tolerated. Most patients experienced tumor shrinkage and symptom improvement, with few serious side effects.

Overall, past studies have shown both treatments to be safe, with most patients managing them well and experiencing generally manageable side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine Lattice Radiotherapy with Chemoimmunotherapy to tackle squamous cell carcinoma in an innovative way. Unlike traditional treatments like surgery, chemotherapy, or standard radiotherapy, Lattice Radiotherapy uses a unique pattern to deliver high doses of radiation to tumors while sparing surrounding healthy tissue. This precise targeting, combined with chemoimmunotherapy, aims to enhance the immune response against cancer cells. By potentially increasing effectiveness and reducing side effects, this approach offers a promising new option for patients with this type of cancer.

What evidence suggests that this trial's treatments could be effective for oropharyngeal squamous cell carcinoma?

This trial will evaluate the combination of induction chemoimmunotherapy and lattice radiotherapy for treating squamous cell carcinoma. Research has shown that combining chemotherapy and immunotherapy, known as induction chemoimmunotherapy, yields promising results for this type of skin cancer. This combination improves survival rates, allowing patients to live longer without cancer spreading and reducing the chances of recurrence in the treated area. For lattice radiotherapy, a targeted radiation treatment, studies indicate it can shrink tumors by about 49% and achieve a six-month survival rate of about 79%. Patients often experience significant tumor shrinkage and symptom relief. This trial will explore how combining these treatments may enhance their overall effectiveness by leveraging both the body's immune response and precise radiation to manage large tumors.16789

Who Is on the Research Team?

KH

Kenneth Hu, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with oropharyngeal squamous cell carcinoma (cancer in the tonsil, base of tongue, soft palate, or back of throat) whose main tumor or lymph node is at least 3 cm. Participants must be able to care for themselves and not be pregnant. Smokers with HPV-positive cancer need a history of more than 10 pack-years.

Inclusion Criteria

I have been diagnosed with squamous cell carcinoma of the oropharynx.
My cancer has spread to nearby lymph nodes but not to distant organs.
My tumor is p16 positive and I have smoked more than 10 pack-years.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Induction chemoimmunotherapy combined with lattice radiotherapy (LRT) to evaluate dose-limiting toxicity and tumor response

Up to 3 weeks
Multiple visits for treatment and monitoring

Response Evaluation

Imaging to determine tumor response; patients with ≥50% shrinkage receive hypofractionated chemoradiation, others receive conventional fractionation

1-2 weeks
1 visit for imaging

Definitive Chemoradiation

Personalized definitive therapy based on tumor response, using either hypofractionated or conventional chemoradiation

Up to 24 months
Regular visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Induction Chemo-Immunotherapy
  • Lattice Radiotherapy

Trial Overview

The study tests a combination of chemoimmunotherapy followed by lattice radiotherapy in people with large or advanced throat cancer. The treatment plan may change based on how much the tumor shrinks after initial therapy. About 60 patients will participate.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: (Cohort PN) Phase II: OBDExperimental Treatment2 Interventions
Group II: (Cohort PN) Phase I: 8 Gy DoseExperimental Treatment2 Interventions
Group III: (Cohort PN) Phase I: 24 Gy DoseExperimental Treatment2 Interventions
Group IV: (Cohort PN) Phase I: 16 Gy DoseExperimental Treatment2 Interventions
Group V: (Cohort P) Phase II: OBDExperimental Treatment2 Interventions
Group VI: (Cohort P) Phase I: 8 Gy DoseExperimental Treatment2 Interventions
Group VII: (Cohort P) Phase I: 24 Gy DoseExperimental Treatment2 Interventions
Group VIII: (Cohort P) Phase I: 16 Gy DoseExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Oncologic outcomes following neoadjuvant ... - PMC

Neoadjuvant immunochemotherapy demonstrated high safety and efficacy in oral SCC. CRT was superior to RT in terms of overall survival especially in patients ...

Low-dose nivolumab plus induction chemotherapy for ...

Rudresha et al. reported a resectability rate of 23.8% after induction chemotherapy in patients with technically unresectable T4a OSCC. The 32% ...

Systematic analysis of chemotherapy, immunotherapy, and ...

This review provides a comparative analysis of chemotherapy, immunotherapy, and combination therapy (CICT) based on clinical trial outcomes.

Safety and effectiveness of induction chemoimmunotherapy ...

No treatment-related deaths occurred. After median follow-up of 16.5 months, the median progression-free survival (PFS) was 14.2 months, and median overall ...

Improving Outcomes While Reducing Toxicity

Key Points: Chemotherapy improves survival in HPV-positive locoregionally advanced head and neck cancer. A survival advantage of induction ...

Induction chemotherapy combined with immunotherapy ... - PMC

This study aimed to explore the efficacy and safety of sintilimab combined with induction chemotherapy (IC) in locally advanced head and neck squamous cell ...

Induction pembrolizumab plus cisplatin and 5-FU ...

The study demonstrated promising ORR, progression-free survival rate and acceptable safety profile of induction therapy with pembrolizumab, cisplatin and 5-FU ...

Immunotherapy before surgery induces complete response ...

63.3% of patients with stage II–IV cutaneous squamous cell carcinoma (CSCC) saw their tumors nearly or completely disappear when treated with immunotherapy ...

The safety and efficacy of induction chemoimmunotherapy ...

The median follow-up period was 20.1 (1.9-44.1) months, and median PFS was not reached, the 24-months PFS rate was 77.6% (95%CI, 59.9%-88.2%). The objective ...