Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT03215719
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Carcinoma

Eligibility Criteria

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

Interventions

  • Standard Radiation Treatment — RADIATION
    An interval scan at 4 weeks to assess for a good response defined as \>40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (\>40% nodal shrinkage). Those with nodal shrinkage and clearance of circulating plasma HPV DNA shall undergo further treatment de-escalation.
  • Dose-Deescalated Treatment — RADIATION
    Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons
  • Cisplatinum — DRUG
    Standard of care chemotherapy

Study Details

This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.

Key Dates

Start date
Oct 18, 2017
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Dose de-escalation (6 weeks)
    26 participants demonstrating a favorable response defined as \>40% nodal shrinkage were eligible to receive the de-escalated treatment regimen (6 doses of weekly cisplatinum with 6 weeks of radiation to a total dose of 60Gy). This arm is closed and has been replaced with Arm 3.
  • Active Comparator: Arm 2: Standard radiation therapy + cisplatinum (7 weeks)
    Participants will receive standard radiation therapy and cisplatinum for 7 weeks.
  • Experimental: Arm 3: Dose de-escalation (6 weeks)
    For participants who achieve (a) rapid nodal shrinkage on interval CT scan but slow / unknown ctHPV DNA clearance OR (b) slow nodal shrinkage on interval CT scan but rapid ctHPV DNA clearance at week 4, radiation treatment will be de-escalated to a total dose of 60Gy/6 weeks with 6 doses of weekly (cisplatinum). This arm replaced Arm 1.
  • Experimental: Arm 4: Dose de-escalation (5 weeks)
    For participants who achieve both a favorable nodal response (\>40%) on interval CT scan as well as rapid ctHPV DNA clearance at week 4, radiation treatment will be further de-escalated to a total dose of 50 Gy/5 weeks with 5 doses of weekly cisplatinum).

Primary Outcome Measure

Progression-free survival at 2 years [ Time Frame: 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016
Kenneth Hu
[email protected]
212-731-5003
Kenneth Hu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
New York University School of Medicine· New York, NY

Related Studies