Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

NCT04444869 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2017520
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

Conditions

Cancer of the Head and Neck; Oropharynx Cancer; HPV Positive Oropharyngeal Squamous Cell Carcinoma; Throat Carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of PEG tube placement

  To determine rate of PEG tube placement

  During the procedure

Secondary Outcomes (6)

• Progression-free survival

  Two years post treatment

• Dysphagia index

  Baseline, 1 month and 6 months after treatment

• Patient Reported Outcomes

  Baseline and 1, 6, and 12 months after end of treatment

• Survival

  At 6 months and at 2 years

• Toxicity profiles

  1 year and 2 years post treatment

Study Arms (1)

Open label single-arm study

OTHER

All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes.

Drug: Cisplatin injection

Interventions

Cisplatin injection DRUG

Standard dose cisplatin given concurrently with radiation therapy

Open label single-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
• Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
• Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
• Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
• Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
• General history and physical examination within 30 days prior to registration;
• Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration;
• One of the following combinations of imaging is required within 45 days prior to registration:
• A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);
• or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);
• or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast);
• or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
• Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools.
• Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.

You may not qualify if:

• Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
• Carcinoma of the neck of unknown primary site origin (even if p16 positive);
• T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
• Radiographically matted nodes, that span 6 cm or more; N3 disease
• Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
• Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
• Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
• Simultaneous primary cancers or separate bilateral primary tumor sites;
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65203, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gregory Biedermann, MD

  University of Missouri - Ellis Fischel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Biedermann, MD

CONTACT

(573) 884-8264; biedermanng@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology / Radiation Oncologist

Model Details: All patients are treated with the same approach.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 24, 2020
• Study Start: September 28, 2020
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)