Clinical Trials Logo
  1. Home
  2. Head and Neck Neoplasms
  3. NCT03077243

P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC

Head and Neck Neoplasms Clinical Trial

Official title:
LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers

Clinical Trial Summary

The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with > 10 pack years smoking history. Hypothesis: Patients with HPV-associated OPSCC, > 10 pack years smoking history, and non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with < 10 pack years smoking history.

Clinical Trial Description

The proposed study is a follow-up study to LCCC 1120 and 1413. The investigators have shown that de-intensification is efficacious in these two phase II studies. A major question is whether the investigators can de-intensify in patients with HPV-associated oropharyngeal cancer who have smoking histories. The investigators' hypothesis is that genomic profiling of patients' tumors (specifically for p53 mutations) will help in triaging patients to de-intensification versus standard of care. Patients with HPV-associated OPSCC will be enrolled regardless of smoking history and p53 mutational status will be assessed in patients with a smoking history. The investigators will use the same de-intensification chemoradiotherapy regimen already evaluated in LCCC 1120 and 1413 in patients with HPV-associated OPSCC who have a minimal smoking history and in patients with a smoking history but with wild-type p53. Patients with a smoking history who have mutated p53 will not receive de-intensified chemoradiotherapy, but instead will receive standard doses. The hypothesis is that by using genomics in the patients with a significant smoking history, the investigators will better select those who can be safely de-intensified. Circulating free HPV DNA (cf-HPV-DNA) will also be prospectively assessed from blood samples. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03077243
Study type Interventional
Source UNC Lineberger Comprehensive Cancer Center
Contact
Status Completed
Phase Phase 2
Start date December 2016
Completion date December 14, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05980598 - TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02548377 - Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Not yet recruiting NCT06347185 - Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study N/A
Terminated NCT02975739 - Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors N/A
Recruiting NCT00982436 - Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer Phase 1/Phase 2
Completed NCT01025518 - DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients N/A
Active, not recruiting NCT00248235 - Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00135161 - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer Phase 1
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Not yet recruiting NCT06458517 - Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers N/A
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Terminated NCT03286972 - PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Recruiting NCT03975465 - EMST and Swallowing in Long-Term Survivors of HNCA N/A
Recruiting NCT03678649 - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC Phase 2
Completed NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] Phase 2
Completed NCT06446570 - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma Phase 2