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Clinical Trials in Mexico / NCT01898494
Active, not recruiting Phase 2

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer

NCT01898494 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2014-01-22
Last updated
2026-04-01

Condition(s) studied

Human Papilloma Virus InfectionStage III Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Oropharynx

Investigational drug(s) / intervention(s)

Transoral surgeryintensity-modulated radiation therapycisplatin →carboplatin →

Transoral surgery: Undergo transoral surgical resection

intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT

cisplatin: Given IV

carboplatin: Given IV

Study summary

This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Registration to Surgery (Arm S) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients must have newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx; patients must have been determined to have resectable oropharyngeal disease; patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible * Patients must have American Joint Committee on Cancer (AJCC) TNM tumor stage III, IV a, or IV b (with no evidence of distant metastases) as determined by imaging studies (performed \< 30 days prior to pre-registration) and complete head and neck exam; the following imaging is required: computed tomography (CT) scan with IV contrast or magnetic resonance imaging (MRI) * Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node. * Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory; using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended * Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer * Patients with the following within the last 6 months prior to pre-registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study * Congestive heart failure \> NYHA Class II * Cerebrovascular accident (CVA)/transient ischaemic attack (TIA) * Unstable angina * Myocardial infarction * Absolute neutrophil count \>= 1,500/mm\^3 * Platelets \>= 100,000/mm\^3 * Total bilirubin =\< the upper limit of normal (ULN) * Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula Registration/Randomization to Step2 - Arms A, B, C and D * Histopathologic assessment of surgical pathology must include examination for perineural invasion (PNI) and lymphovascular invasion (LVI) and reported as absent or present; the absence or presence of extracapsular extension (ECE) requires gross and microscopic assessment and is defined to be: * Absent (negative or nodal metastasis with smooth/rounded leading edge confined to thickened capsule/pseudocapsule), * Present - minimal (tumor extends =\< 1 mm beyond the lymph node capsule), or * Present - extensive (gross, tumor extends \> 1 mm beyond the lymph node capsule (includes soft tissue metastasis) * Patient must be stratified/classified into one of the following risk categories (the highest risk feature assessed pathologically will determine the patient's category/treatment arm assignment): * Low Risk: T1-T2, N0-N1 AND clear (≥ 3mm) margins, AND no ECE or PNI/LVI * High Risk: Any of the following features: one or more positive margin(s) with any T stage, OR "Extensive" (\> 1mm) ECE, OR ≥ 5 metastatic lymph nodes (regardless of primary tumor margin status) * Intermediate Risk: Any of the following features: one or more "close" (\< 3mm) margin(s), OR "Minimal" (≤ 1mm) ECE, OR N2a (1 or more lymph node \> 3cm in diameter), OR N2b (2-4 lymph nodes positive, any diameter ≤ 6cm), OR with perineural invasion or lymphovascular invasion. * Unknown Risk: Patients found to have N2C or N3 disease on final pathologic analysis are at unknown risk for recurrence, but are not candidates for deintensified adjuvant therapy in this trial. These patients will be treated on Arm C. * Patients not categorized into the appropriate risk category will be considered ineligible for the study * Patient must be registered/randomized to Step 2 within a maximum of 7 weeks following surgery * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception Exclusion Criteria: Registration to Surgery (Arm S) * Prior radiation above the clavicles * Evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging * Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Any intercurrent illness likely to interfere with protocol therapy or prevent surgical resection * Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days prior to pre-registration

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Mayo Clinic in Arizona Scottsdale Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
City of Hope Comprehensive Cancer Center Duarte California
UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
Kaiser Permanente Oakland-Broadway Oakland California
Stanford Cancer Institute Palo Alto California
UCSF Medical Center-Mount Zion San Francisco California
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
Porter Adventist Hospital Denver Colorado
Yale University New Haven Connecticut
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Florida Hospital Orlando Orlando Florida
Emory University Hospital Midtown Atlanta Georgia
Emory University/Winship Cancer Institute Atlanta Georgia
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
University of Kansas Cancer Center Kansas City Kansas
University of Kentucky/Markey Cancer Center Lexington Kentucky
Greater Baltimore Medical Center Baltimore Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
Brigham and Women's Hospital Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Boston Medical Center Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Mercy Hospital Springfield Springfield Missouri
Nebraska Methodist Hospital Omaha Nebraska
University of Nebraska Medical Center Omaha Nebraska
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
University of New Mexico Albuquerque New Mexico
Memorial Sloan-Kettering Cancer Center New York New York
Montefiore Medical Center - Moses Campus The Bronx New York
Duke University Medical Center Durham North Carolina
Case Western Reserve University Cleveland Ohio
Cleveland Clinic Foundation Cleveland Ohio
Ohio State University Comprehensive Cancer Center Columbus Ohio
Providence Portland Medical Center Portland Oregon
Oregon Health and Science University Portland Oregon

+ 18 more sites — see the full list on the official registry below.

More ECOG-ACRIN Cancer Research Group trials in Mexico

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01898494 on ClinicalTrials.gov ↗ ← All trials in Mexico