CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
Cisplatin (or alternative) +2 moredrug
Likely dose
Cisplatin (or alternative) 40 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03077243
NCT03077243Phase 2Completed
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LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Mar 10, 2017·Updated May 2, 2024

In Brief

A Phase 2 clinical trial evaluating Intensity Modulated Radiotherapy (IMRT), Cisplatin (or alternative), and 1 other intervention for Carcinoma, Squamous Cell and 2 related conditions. Completed, enrolled 195 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 10, 2017
Enrollment StartDec 1, 2016
Primary CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 9.3 years ago

Interventions

Intensity Modulated Radiotherapy (IMRT)radiation

60- 70 Gy at 2 Gy/fx

Cisplatin (or alternative)drug

The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 -7 total doses.

Assessment for surgical evaluationprocedure

Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.