Clinical Trials Logo
  1. Home
  2. Oropharyngeal Neoplasms
  3. NCT02281955

De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study

Head and Neck Neoplasms Clinical Trial

Official title:
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma

Clinical Trial Summary

The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.

Clinical Trial Description

The proposed study is a follow-up study to NCT01530997. In NCT01530997, patients with HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) received de-intensified chemoradiotherapy (CRT) followed by a limited surgical evaluation. The primary endpoint of NCT01530997 was the rate of pathological complete response (pCR) after CRT. Power computations were performed for N=40 and were based on the null hypothesis (H0) that the pCR for de-intensified chemoradiotherapy is at least 87%, the historical rate. The type 1 error for this calculation was 14.2%. 43 patients enrolled and 38 were evaluable for the primary endpoint. The observed pCR rate was 89% (34/38). Since the observed pCR rate was excellent in NCT01530997 and was in concordance with the expected rate, in the proposed study we will not mandate a post-CRT surgical evaluation. Instead a PET/CT 10 to 16 weeks post-CRT will be used to determine whether a surgical evaluation is needed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02281955
Study type Interventional
Source UNC Lineberger Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 2014
Completion date November 2024
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 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
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Completed NCT00135161 - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer Phase 1
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 NCT03678649 - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC Phase 2
Recruiting NCT03975465 - EMST and Swallowing in Long-Term Survivors of HNCA N/A
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 NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Recruiting NCT03981068 - DAHANCA 37. Re-irradiation With Proton Radiotherapy N/A
Completed NCT02254018 - Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Phase 1