Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity

Withdrawn before enrolling · Not applicable

Conditions studied: Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

In brief

This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.

Key facts

Study ID: NCT02295540
Run by: Rutgers, The State University of New Jersey
People needed: 0
Starts: 2016-08-01
Expected to finish: 2020-01-01
Last updated by the study team: 2022-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is willing to sign study specific informed consent
Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head \& neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology
Patient is deemed to be a surgical candidate by ENT
Karnofsky performance status (KPS) 0-2
For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (CD4) count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (HAART) is allowed
Patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years

You may not qualify if…

Metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (PET)/CT or biopsy
KPS 3 or worse
Gross disease in the retrostyloid (high level II) or retropharyngeal lymph node regions by CT or PET/CT
Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
Women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Patient is deemed to not be a surgical candidate by ENT

Where it is running

Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
New Jersey Medical School — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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