Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jonathan Schoenfeld, MD, MPH
Study ID
NCT04900623
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Associated Oropharyngeal Squamous Cell Carcinoma
  • HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage
  • HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage
  • HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Stage
  • HPV-Related Squamous Cell Carcinoma
  • Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Eligibility Criteria

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

Interventions

  • NavDx HPV ctDNA Testing — DEVICE
    Blood will be collected and shared with an outside lab for analysis. This test will be done at Week 4 and at End of Treatment. This test will be done at at End of Treatment and in follow-up at 3, 6, 9, and 12 months after completing the study treatment. In years 2 and 3 after treatment, the test will be collected every 6 months or twice a year. The specimens will be identifiable. The specimens will be banked for future use.
  • Radiotherapy — RADIATION
    Radiation Therapy (administered daily, Monday-Friday). Higher risk participants will receive standard radiation dose for up to 7-8 weeks. Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks.
  • Chemotherapy drug — DRUG
    Chemotherapy and radiation therapy are both considered standard treatments * Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. * Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy.

Study Details

This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)

Key Dates

Start date
Jul 2, 2021
Status verified
Jul 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2032

Study Design

Enrollment
145 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LOW RISK RT (ALONE OR WITH SOC CHEMO
    The research study procedures include: screening for eligibility, and study treatments including evaluations and follow-up visits * NavDx HPV ctDNA Testing: Blood will be collected and shared with an outside lab for analysis (less than 10 mL of blood or about 2 teaspoons). The results of this test will determine what radiation dose received . The specimens will be de-identified. The specimens will be banked for future use. * Radiation Therapy: Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks. * Chemotherapy: Chemotherapy and radiation therapy are both considered standard treatments for your type of cancer. The study doctor will decide whether or not chemotherapy with radiation and the type of chemotherapy. * Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. * Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy
  • Experimental: INTERMEDIATE RISK RT (ALONE OR WITH SOC CHEMO
    The research study procedures include: screening for eligibility, and study treatments including evaluations and follow-up visits * NavDx HPV ctDNA Testing: Blood will be collected and shared with an outside lab for analysis (less than 10 mL of blood or about 2 teaspoons). The results of this test will determine what dose of radiation received. The specimens will be de-identified. The specimens will be banked for future use. * Radiation Therapy: Higher risk participants will receive standard radiation dose for up to 7-8 weeks * Chemotherapy: Chemotherapy and radiation therapy are both considered standard treatments for your type of cancer. The study doctor will decide whether or not chemotherapy with radiation and the type of chemotherapy. * Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. * Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy

Primary Outcome Measure

Progression Free Survival 2 Years [ Time Frame: 2 Years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jonathan Schoenfeld, MD, MPH
[email protected]
617.632.5296
Jonathan Schoenfeld, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Jonathan D. Schoenfeld, MD, MPH
[email protected]
617.632.5296
Jonathan D. schoenfeld, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

Related Studies