Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Zachary Zumsteg
Study ID
NCT06445114
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation. Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.

Study Details

This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.

Key Dates

Start date
May 12, 2025
Status verified
May 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation. Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.

Primary Outcome Measure

2-year progression-free (PFS) [ Time Frame: 2 Years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Cancer at Beverly Hills (THO)Beverly HillsCalifornia90211
Clinical Trial Recruitment Navigator
Kevin Scher, MD (SUB_INVESTIGATOR)
David Hoffman, MD (SUB_INVESTIGATOR)
Kamalesh Sankhala, MD (SUB_INVESTIGATOR)
Leland Green, MD (SUB_INVESTIGATOR)
Jeremy Lorber, MD (SUB_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Zachary S Zumsteg, MD
[email protected]
310-248-8375
Allen Ho, MD (SUB_INVESTIGATOR)
Jon Mallen-St. Clair, MD (SUB_INVESTIGATOR)
Evan Walgama, MD (SUB_INVESTIGATOR)
Alain Mita, MD (SUB_INVESTIGATOR)
Jun Gong, MD (SUB_INVESTIGATOR)
Ronald Natale, MD (SUB_INVESTIGATOR)
Stephen Shiao, MD (SUB_INVESTIGATOR)
Julie Jang, MD (SUB_INVESTIGATOR)
Zachary S Zumsteg, MD (PRINCIPAL_INVESTIGATOR)
CS Cancer at Valley Oncology Medical GroupTarzanaCalifornia91356
Vanessa Vasco
[email protected]
Benjamin L King, MD (SUB_INVESTIGATOR)
Robert S Reznik, MD (SUB_INVESTIGATOR)
Natasha Banerjee, MD (SUB_INVESTIGATOR)
Johnny K Chang, MD (SUB_INVESTIGATOR)
Ryan Ponec, MD (SUB_INVESTIGATOR)
Anirban Balmanoukian, MD (SUB_INVESTIGATOR)
CS Cancer at the Hunt Cancer CenterTorranceCalifornia90505
Sarah Valdez
[email protected]
310-750-3300
Hugo Hool, MD (SUB_INVESTIGATOR)
Vanessa Dickey, MD (SUB_INVESTIGATOR)
David Chan, MD (SUB_INVESTIGATOR)
Syed Jilani, MD (SUB_INVESTIGATOR)
Thomas Lowe, MD (SUB_INVESTIGATOR)
Swati Sikaria, MD (SUB_INVESTIGATOR)
Andrew Horodner, MD (SUB_INVESTIGATOR)
Bryan Chang, MD (SUB_INVESTIGATOR)
Thyra Endicott, MD (SUB_INVESTIGATOR)
Andrew Schumacher, MD (SUB_INVESTIGATOR)
Usama Mahmood, MD (SUB_INVESTIGATOR)
Rebecca Philipson, MD (SUB_INVESTIGATOR)

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