Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

Официальное название

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)

Обзор

This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.

Подробное описание

The purpose of this research is to determine if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treatment, while reducing the side effects of radiation and improving quality of life.

The current standard care treatment for OPSCC can have debilitating side effects. Using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating cancer with less side effects. The combination of these approaches is not considered the current standard of care. Patients will continue to receive standard systemic therapy of cisplatin during radiation therapy.

Вмешательства

• Препарат Cisplatin
  Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no late
• Лучевая терапия Radiotherapy
  Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.

Первичные конечные точки

• Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS) [Срок оценки: 2 years post treatment]

Вторичные конечные точки (3)

• Safety evaluated per CTCAE v6 [Срок оценки: Adverse events collected through 30 days post treatment and SAEs through 90 days post-treatment or until commencement of new anti-cancer therapy, whichever occurs first.]
• Quality of life measured by MDADI [Срок оценки: Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT]
• Quality of life measured by EORTC QLQ-C30 [Срок оценки: Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT]

Критерии участия

Критерии включения

• Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
• Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
• OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
• Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
• Age ≥18 years.
• ECOG performance status ≤2.
• Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
• Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• 1\. Patients with metastatic or recurrent disease.

2\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).

3\. Prior radiotherapy resulting in overlap of radiation therapy fields.

4\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.

5\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.

6\. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator.

7\. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Cincinnati Medical Center — Cincinnati

Идентификаторы

NCT: NCT07497607 · UCCC-RT-25-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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