Health Trials

The Minimalist Trial-2

ConditionHPV-Related Oropharynx Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (\>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy.

However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate.

In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to:

* Arm 1 (de-POACRT-42 Gy) * Arm 2A (de-POART-42 Gy) * Arm 2B (de-POART-37.8 Gy) * Arm 2C (de-POACRT-30 Gy).

All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.

Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).

Planned unilateral or contralateral selective neck dissection.

ECOG PS 0-2.

Disqualifiers

Clinical T1N0M0 or T2N0M0 disease.

Prior radiation therapy for HNSCC.

Planned free-flap reconstruction of the resected primary site.

Cirrhosis with Child-Pugh Score B or C.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation therapy

    Radiation

    IMRT or IMPT

  • Cisplatin

    Drug

    Dose of 100 mg/m\^2 IVPB over 60 minutes

  • Surgery

    Procedure/Surgery

    Standard of care

Treatment groups

142 Participants
are divided into 4 treatment groups
Group A: Arm 1: Radiation therapy + CisplatinExperimental treatment 3 interventions
Group B: Arm 2A: Radiation therapyExperimental treatment 2 interventions
Group C: Arm 2B: Radiation therapyExperimental treatment 2 interventions
Group D: Arm 2C: Radiation therapy + CisplatinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Recurrence rate

Time frame
At 2 years

Secondary outcomes

1

Percent weight loss

For assessing percent weight loss, weight (kg) will be collected weekly during radiation within each arm, starting at Day 1 of RT and ending on the last day of RT. The percent weight loss from the baseline is calculated at any post-baseline.

Time frame
From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
2

Proportion of patients undergoing PEG tube placement

Time frame
Through completion of follow-up (estimated to be 5 years and 10 weeks)
3

Duration of need for an indwelling PEG tube

Time frame
Through completion of follow-up (estimated to be 5 years and 10 weeks)
4

Proportion of patients taking narcotic

Time frame
Through completion of follow-up (estimated to be 5 years and 10 weeks)

Other outcomes

Sponsors and contacts

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

Washington University School of Medicine

Lead sponsor

The Joseph Sanchez Foundation

Collaborator

Source ClinicalTrials.gov
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