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Alkylating agents

Chemoradiation for Oropharyngeal Cancer

Phase 2
Recruiting
Led By Zachary S Zumsteg, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Have at least one of the following after surgery: Pathologic stage T3, 2 or more positive lymph nodes, At least one lymph node >3cm, Lymphovascular invasion, Perineural invasion, Extranodal extension, Close/positive margins: Close margins are considered <3mm from the peripheral margins and <1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare a de-intensified version of standard chemoradiation against standard chemoradiation in patients with HPV-associated oropharyngeal cancer.

Who is the study for?
Adults with HPV-positive oropharyngeal cancer who've had surgery to remove the cancer can join this trial. They must be in good health, not pregnant, and have no recent other cancers or severe illnesses. People with very advanced disease, distant spread of cancer, inability to completely remove the tumor surgically, significant heart issues within the last 6 months, uncontrolled infections or AIDS cannot participate.Check my eligibility
What is being tested?
The study is testing a less intense version of chemoradiation therapy using cisplatin after robotic surgery for HPV-related throat cancer. It aims to see if lower doses are as effective but cause fewer side effects than standard treatment. High-risk patients will receive more intensive treatment.See study design
What are the potential side effects?
Possible side effects include nausea and vomiting from chemotherapy; skin redness and soreness where radiation is given; fatigue; hearing loss; kidney damage; blood cell count changes leading to increased infection risk, bleeding problems or anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My surgery showed I have advanced cancer features.
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I have had or will have surgery to remove lymph nodes in my neck.
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My cancer started with an unknown primary but has spread to at least one lymph node in my neck.
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My tumor is mostly positive for p16 in its cells.
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My cancer is in the throat area and has not spread widely.
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I will have or had surgery to remove all visible cancer in my head or neck.
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My blood, liver, and kidney tests are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-Year Progression-Free Survival (PFS)
Secondary outcome measures
Cause-specific Survival
Distant Control
Local Control
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: De-intensified Cisplatin-based ChemoradiationExperimental Treatment2 Interventions
This is a non-randomized study, with all patients undergoing de-intensified post-operative cisplatin-based chemoradiation. Dosage level and duration of administration will be determined by whether the patient is high risk or not as assessed by the treating investigator.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,823 Total Patients Enrolled
Zachary S Zumsteg, MDPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04502407 — Phase 2
Oropharyngeal Carcinoma Research Study Groups: De-intensified Cisplatin-based Chemoradiation
Oropharyngeal Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04502407 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502407 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How successful have earlier experiments been with Cisplatin Chemotherapy?

"Currently, there are 689 active clinical trials researching Cisplatin Chemotherapy with 274 of them in their final stage. Primarily situated in Shanghai, China, a total of 43222 sites have studies dedicated to this chemotherapy drug."

Answered by AI

What potential risks do patients face when undergoing Cisplatin Chemotherapy?

"As the Cisplatin Chemotherapy is currently undergoing a Phase 2 trial, it has been allocated a safety score of 2 as there is some clinical evidence reinforcing its security but no data to support efficacy."

Answered by AI

Are there any open spots at the moment in this experiment?

"Affirmative. The clinical trial's information on clinicaltrials.gov verifies that it is presently searching for individuals to participate in the study. This medical experiment, which was initially advertised on February 16th 2021, requires 36 participants across 4 different sites."

Answered by AI

At what number of healthcare centers can this research trial be accessed?

"Currently, 4 sites are enrolling patients in this trial. These include Tarzana, Los Angeles and Torrance as well as several other nearby locations. Choosing the closest site to you can reduce any travel-related burdens associated with participation."

Answered by AI

What types of treatments are Cisplatin Chemotherapy commonly prescribed for?

"Cisplatin Chemotherapy is widely prescribed to treat advanced ovarian cancer, as well as multiple other diseases that require stronger interventions like refractory testicular cancers."

Answered by AI

What is the uppermost limit of participants in this trial?

"Affirmative. The information accessible on clinicaltrials.gov confirms that this research project, which was initially posted in February 2021, is presently recruiting participants. Around 36 individuals need to be enrolled from 4 distinct medical locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
Zachary Zumsteg 2021. "Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502407.
~18 spots leftby Dec 2026
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