Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer

NCT02703493 | Completed DMC

• 1 other identifier: 09-309A
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study looking to evaluate the safety of dose escalated stereotactic radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.

Conditions

Cancer of the Oropharynx

Outcome Measures

Primary Outcomes (1)

• Safety and dose-limiting toxicity of dose escalated stereotactic radiotherapy in patients with high-risk oropharyngeal squamous cancer using (CTCAE), version 4.03

  study completed.

  up to two years post SRS Boost

Secondary Outcomes (1)

• Disease response using Revised RECIST guideline (version 1.1)

  up to two years post SRS Boost

Study Arms (1)

Cohort 1

EXPERIMENTAL

Patients will receive 6 weeks of Intensity-Modulated Radiation Therapy (IMRT) (standard of care) followed by the dose escalated stereotactic radiosurgery (SRS Boost). Cohort 1 will receive 8 Gy in a single fraction, cohort 2 will receive 10 Gy in a single fraction and cohort 3 will receive 10 Gy split into two fractions.

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Patients will receive 6 weeks of IMRT (standard of care) followed by the stereotactic radiosurgery (SRS Boost). Dose of the boost is reliant on which cohort the patient is assigned to. Cohort 1 will receive 8 Gy, Cohort 2 will receive 10 Gy in a single fraction, Cohort 3 will receive 10 Gy split into two fractions.

Also known as: SRS

Cohort 1

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx
• HPV-negative disease status by routine p16 immunohistochemical (IHC) staining or in situ hybridization (ISH) of biopsied tumor tissue or \>10 pack-year cigarette smoking history
• Stage T1-4, N0-3 disease, as defined by American Joint Committee on Cancer (AJCC) criteria
• Eastern Cooperative Oncology Group (ECOG) (Zubrod) Performance Status 0-2.

You may not qualify if:

• Patients who have undergone resection of primary disease
• Patients who have received induction chemotherapy for their oropharynx cancer diagnosis
• Prior cancer diagnosis within 5 years, except appropriately treated localized epithelial skin cancer or cervical cancer
• Prior radiation therapy to the head and neck region
• Women of childbearing potential (a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
• Patient unable to tolerate MRI or having an estimated Glomerular Filtration Rate (GFR) \<60 ml/min/1.73 m2.
• 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
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
• Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
• History or treatment with potent immunosuppressive drugs for such conditions as organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health- Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

Related Publications (1)

• Vempati P, Halthore AN, Teckie S, Rana Z, Gogineni E, Antone J, Zhang H, Marrero M, Beadle K, Frank DK, Aziz M, Paul D, Ghaly M. Phase I trial of dose-escalated stereotactic radiosurgery (SRS) boost for unfavorable locally advanced oropharyngeal cancer. Radiat Oncol. 2020 Dec 11;15(1):278. doi: 10.1186/s13014-020-01718-w.

  PMID: 33308265 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maged Ghaly, MD

  Northwell Health- Center for Advanced Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dose escalation of radiation therapy for high risk oropharyngeal cancer

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: March 9, 2016
• Study Start: March 1, 2010
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)