Transoral Surgery + Reduced-Dose Radiation/Chemotherapy for Oropharyngeal Cancer

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Metastatic disease, Serious systemic disorders, Age < 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining surgery with reduced doses of radiation and chemotherapy can effectively treat HPV-related throat cancer while enhancing quality of life. It focuses on patients who have undergone transoral surgery to remove the cancer, with treatment plans tailored to the risk of recurrence. Eligible participants are those diagnosed with squamous cell carcinoma of the oropharynx who have not yet received chemotherapy or radiation. As a Phase 2 trial, this research measures 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?

Previous studies have shown that surgery through the mouth is safe for treating oropharyngeal cancer, a type of throat cancer. Patients typically recover well after surgery, with few major complications. External beam radiation therapy (EBRT), another component of the treatment, generally proves effective but can cause side effects like a sore throat or difficulty swallowing. This trial aims to reduce these side effects by using lower doses.

Cisplatin, a chemotherapy drug, is also included in the treatment plan. While it can cause side effects such as nausea or fatigue, a lower dose might make it more manageable for patients.

This trial is in its early stages, so the safety of the treatment remains under study. However, the use of lower doses for both radiation and chemotherapy aims to make the treatment gentler while maintaining effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the transoral surgery combined with reduced-dose radiation and chemotherapy because it offers a potentially less invasive and more targeted approach for treating oropharyngeal cancer. Unlike the standard treatment, which typically involves high-dose radiation and chemotherapy, this method aims to reduce the treatment intensity while still effectively managing the cancer. The treatment is tailored to the risk level of recurrence, with low-risk patients undergoing surgery and observation, while medium and high-risk patients receive reduced-dose external beam radiation therapy (EBRT) with or without cisplatin chemotherapy. This approach could lead to fewer side effects and a better quality of life for patients without compromising the effectiveness of the cancer treatment.

What evidence suggests that this trial's treatments could be effective for HPV-caused throat cancer?

This trial will compare different treatment approaches for oropharyngeal cancer. Research has shown that transoral surgery, one of the treatments in this trial, effectively treats throat cancer caused by HPV, with some studies reporting over 93% survival for HPV-positive cases. For patients who have undergone similar surgeries, the overall survival rate can reach 94% five years later.

External beam radiation therapy (EBRT), another treatment option in this trial, has effectively treated throat cancer, especially with recent technological improvements. These advancements have made radiation therapy a powerful tool for controlling cancer.

Cisplatin, a chemotherapy drug used in one of the trial arms, is often combined with radiation and has proven effective in treating throat cancer. Research indicates that when used weekly, cisplatin helps achieve high survival rates, particularly in HPV-positive patients. Overall, these treatments together offer a promising approach for managing throat cancer caused by HPV. ^{1 3 6 7 8}

Who Is on the Research Team?

Matin Imanguli, MD, DDS

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults with HPV-related throat cancer that can be surgically removed. Participants must have certain blood and organ function levels, not have had previous treatments for head and neck cancer, and women of childbearing age must test negative for pregnancy and use birth control. People with metastatic disease beyond the neck or serious health issues are excluded.

Inclusion Criteria

Platelets >= 100,000/ul

Must give informed consent

Negative pregnancy test, if applicable

Exclusion Criteria

I have not had treatment for my head and neck cancer, except for a biopsy.

I had another type of cancer but have been cancer-free for 3 years, or I have in situ carcinoma or non-melanoma skin cancer.

I am not pregnant and agree to use birth control during and 6 months after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo transoral surgery to remove the tumor

1 week

1 visit (in-person)

Adjuvant Therapy

Participants receive reduced dose radiation therapy and chemotherapy based on risk group

5-6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• External Beam Radiation Therapy
• Transoral Surgery

Trial Overview The study tests if lower doses of radiation therapy and chemotherapy after surgery can maintain survival rates while improving quality of life in patients with HPV-caused throat cancer. It's a phase II trial where everyone gets the same treatment without being randomly assigned to different groups.

How Is the Trial Designed?

Group I: GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2) Experimental Treatment 9 Interventions

Patients whose tumor has a "positive margin", which means the tumor could not be removed with healthy tissue around it or tumor grows significantly outside the lymph node will undergo EBRT RT 60 Gy for 6 weeks and receive cisplatin intravenously (IV) weekly 30mg/m2 for 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy) Experimental Treatment 8 Interventions

Patients whose tumor was removed completely but has certain features that make it more likely to come back such as growth around the nerves or into the vessels, or has more than one lymph nodes involved, will undergo external body radiation therapy (EBRT) RT 50Gy for 5 weeks in the absence of disease progression or unacceptable toxicity.

Group III: GROUP I - Low Risk Recurrence (transoral surgery, clinical observation)) Active Control 7 Interventions

After standard of care transoral surgery, patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6363014/

Concurrent chemotherapy in oropharyngeal cancer The study findings demonstrated that when compared to concurrent CDDP, CTX did not meet criteria for non-inferiority as OS was significantly worse (p = 0.0163) ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827612

Weekly Cisplatin Cycles and Outcomes for Chemoradiation ... These findings suggest that missing several cycles of weekly cisplatin is associated with worse survival, even among those with p16-negative tumors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11513364/

Retrospective study of cisplatin plus radiotherapy toxicities ... A total of 274 (84%) patients were compliant and received the planned dose of cisplatin. Overall, 957 adverse events were reported in 98.2% of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623048095

Effectiveness of Cisplatin in P16+ Oropharyngeal Cancer ... The effectiveness of cisplatin in p16+ OPSCC increased with higher omega score but not with standard risk group.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.01293

Weekly Cisplatin Plus Radiation for Postoperative Head ... Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169397/

Comparing the efficacy and safety of cisplatin and other ... There was no significant difference in the 3- and 5-year overall survival, progression-free survival, distant metastasis-free survival, and locoregional relapse ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814625000732

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 ...

8. nrgoncology.org nrgoncology.org/Home/News/Post/reduced-dose-radiation-with-cisplatin-improves-outcomes-for-hpv-associated-oropharyngeal-carcinoma-patients-on-nrg-oncology-study-justifies-phase-iii-trial

Reduced-Dose Radiation with Cisplatin Improves Outcomes f 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 ...