Is NCT04900623 recruiting in Boston, MA?

Yes, NCT04900623 is currently recruiting participants at its Boston, MA location. This oropharyngeal cancer clinical trial is actively enrolling qualified participants.

How do I join the oropharyngeal cancer clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Oropharyngeal Cancer Clinical Trial in Boston, MA

About This Oropharyngeal Cancer Study in Boston

This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)

Sponsor: Jonathan Schoenfeld, MD, MPH

Who Can Participate

Inclusion Criteria

Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:

Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. \-- Patients with HPV-associated disease of unknown primary (cT0) are eligible

HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following:

Immunohistochemical staining for p16 with ≥70% expression

Confirmatory DNA testing (PCR or ISH) for high-risk subtype

Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment.

Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16

Age 22 years or older

ECOG performance status ≤ 2

Participants should have adequate organ and marrow function if they are to receive chemotherapy (cisplatin, or carboplatin and paclitaxel) with radiation concurrently as determined by standard institutional guidelines and investigator preference (parameters suggested below).

absolute neutrophil count (ANC) ≥ 1000

platelet count ≥ 100,000

total bilirubin of 1.5 or less

creatinine of 1.6 or less (or a CrCl ≥50 mL/min) per institutional standards.

Planning to receive non-surgical management for HPV+ oropharyngeal cancer

Ability to understand and the willingness to sign a written informed consent document.

Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy. "Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level above 40 mIU/mL.

Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.

Exclusion Criteria

Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or N3 disease as suggested by lymph nodes measuring \>6 cm.

Subject who has had prior radiation and/or chemotherapy for head and neck cancer.

Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation. Note: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is/are acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.

Undetectable baseline HPV ctDNA result by NavDx® testing or detectable baseline HPV ctDNA result for subtypes 18, 31, 33, or 35.

Pregnant or lactating women.

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance3 of recurrence is thought to be low.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04900623) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Oropharyngeal Cancer Treatment Options in Boston, MA

If you're searching for oropharyngeal cancer treatment options in Boston, MA, this clinical trial (NCT04900623) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced oropharyngeal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all oropharyngeal cancer clinical trials near you to find additional studies recruiting in your area.

Oropharyngeal Cancer Clinical Trial in Boston, MA

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