The Minimalist Trial-2

Conditions

• HPV-Related Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Radiation therapy — RADIATION
  IMRT or IMPT
• Cisplatin — DRUG
  Dose of 100 mg/m\^2 IVPB over 60 minutes
• Surgery — PROCEDURE
  Standard of care

Study Details

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.

Key Dates

Start date

Apr 10, 2025

Status verified

May 2026

Primary completion

Apr 30, 2030

Completion

Jul 15, 2033

Study Design

Enrollment

142 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Radiation therapy + Cisplatin
  * Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
• Experimental: Arm 2A: Radiation therapy
  * Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
• Experimental: Arm 2B: Radiation therapy
  * Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each.
• Experimental: Arm 2C: Radiation therapy + Cisplatin
  * Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.

Primary Outcome Measure

Recurrence rate [ Time Frame: At 2 years ]

Central Contacts

• Douglas Adkins, M.D.
  314-747-8475
  [email protected]

Locations (3)

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