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

ConditionsHPV-Associated Oropharyngeal Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 StageHPV-Related Squamous Cell CarcinomaClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22+
SponsorJonathan Schoenfeld, MD, MPH

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging.

Immunohistochemical staining for p16 with ≥70% expression

Confirmatory DNA testing (PCR or ISH) for high-risk subtype

Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment.

Disqualifiers

Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or N3 disease as suggested by lymph nodes measuring >6 cm.

Subject who has had prior radiation and/or chemotherapy for head and neck cancer.

Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation. Note: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is/are acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.

Undetectable baseline HPV ctDNA result by NavDx® testing or detectable baseline HPV ctDNA result for subtypes 18, 31, 33, or 35.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

145 Participants
are divided into 2 treatment groups
Group A: LOW RISK RT (ALONE OR WITH SOC CHEMOExperimental treatment 3 interventions
Group B: INTERMEDIATE RISK RT (ALONE OR WITH SOC CHEMOExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival 2 Years

Progression-free survival (PFS) is defined as the time from the date of study registration to first invasive local, regional, distant progression, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation

Time frame
2 Years

Secondary outcomes

1

Overall Survival at 2 Years

Defined as the time from study registration to death due to any cause, or censored at date last known alive.

Time frame
2 Years
2

Rate of Distant Failure

Distant metastatic-free survival (DMFS) is defined as the time from confirmed disease response (CR/PR) to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause. Participants alive without distant or metastatic progression are censored at date of last disease evaluation.

Time frame
every 12 weeks (or 3 months) from the time of therapy completion for years 1 and 2, and every 24 weeks (or 6 months) from the time of therapy completion in year 3.
3

Best Overall Response

The best response recorded from the start of the treatment until disease progression or recurrence, with documentation of local (primary site) or regional (neck lymph node) disease clearance being of interest. Clinical or radiographic evidence of progressive locoregional disease beyond 12 weeks (or 3 months) from the end of treatment should be documented and ideally confirmed by locoregional or distant disease biopsy, neck dissection, or salvage surgery. CT or MRI (of head and neck region, with chest CT), or PET-CT may be used as radiographic evaluation of overall disease status.

Time frame
every 12 weeks (or 3 months) from the time of therapy completion for years 1 and 2, and every 24 weeks (or 6 months) from the time of therapy completion in year 3.
4

Score Change FACT-H&N survey data

The self-administered Functional Assessment of Cancer Therapy - Head \& Neck Cancer (FACT-HN) questionnaire consists of FACT-G, a cancer specific QOL questionnaire that includes 27 questions in 4 domains - physical, social, emotional, and function, and a 12-time H\&N cancer-specific modules. Each item is rated on a 0 to 4 scale. Higher scores represent better Quality of Life. A clinically significant change in score on this instrument is represented by an increase of 6 units or decrease of 12 units

Time frame
baseline up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonathan Schoenfeld, MD, MPH

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Naveris

Collaborator

Source ClinicalTrials.gov
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