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

Summary

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.

Eligibility

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
5. Age ≥18 years.
6. ECOG performance status ≤2.
7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
8. 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.
9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* 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.

Conditions3

Interventions1

Locations1 site

Find trials near these locations

Related trials

• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors — Mabwell (Shanghai) Bioscience Co., Ltd.
• A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer — Shanghai Jiao Tong University School of Medicine
• A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma — Renmin Hospital of Wuhan University
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

Browse More Trials