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

ConditionsOropharyngeal CancerCarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZachary Zumsteg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.

For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.

p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.

Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.

Disqualifiers

AJCC 8th edition pT4 or cN3 disease.

Radiologic or clinical evidence of distant metastasis.

Recurrent disease.

Inability to achieve gross total resection at time of surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year progression-free (PFS)

The primary objective of this study is to assess the 2-year progression-free survival (PFS) of de-intensified post-operative chemoradiation in patients with HPV-associated oropharyngeal cancer when basing treatment intensity on both standard pathologic features and post-operative Blood-based circulating tumor tissue modified viral (cTTMV-HPV DNA)

Time frame
2 Years

Secondary outcomes

1

Overall Survival (OS)

Proportion of patients alive, based on time from enrollment to death from any cause.

Time frame
2 Years
2

Locoregional Control

Proportion of patients without local recurrence or regional recurrence, as defined above, based on the time from enrollment to the first evidence of either local or regional recurrence, irrespective of prior distant recurrence. Death from causes unrelated to cancer is a competing event.

Time frame
2 Years
3

Distant Control

Proportion of patients without distant recurrence, based on time from enrollment to distant recurrence, irrespective of prior local or regional recurrence. Distant metastasis includes any recurrent disease outside of the head and neck, cervical lymph nodes, or retropharyngeal lymph nodes. Death from causes unrelated to cancer is a competing event.

Time frame
2 Years
4

Cause-Specific Survival

Proportion of patients without oropharyngeal cancer-related or treatment-related death, based on time from enrollment to death from oropharyngeal cancer or treatment. Death from other causes is a competing event.

Time frame
2 Years

Other outcomes

Sponsors and contacts

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

Zachary Zumsteg

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov
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