Clinical trial NCT02295540: Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity
Official title: Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2014-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Preoperative hypofractionated radiation followed by surgical resection
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. 2 year locoregional control for advanced oral cavity squamous cell carcinoma (SCC) treated with preoperative hypofractionated radiation followed by surgical resection.

SECONDARY OBJECTIVES:

I. Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes (LN).

II. Rate of radiologic complete and partial response (computed tomography \[CT\] neck with intravenous \[IV\] contrast performed before and after radiation therapy, judged per Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 criteria).

III. Grade III/IV/V toxicity both short term (from start of radiation to 60 days after surgery) and long term (more than 60 days after surgery).

IV. Rate of flap complications: Rate of flap revisions, and complete revisions required.

V. Molecular correlates. VI. Quantitative imaging correlates.

OUTLINE:

Patients undergo hypofractionated intensity-modulated radiation therapy (IMRT) every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Locoregional control
timeFrame: 2 years
Secondary outcomes:
measure: Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes
timeFrame: Up to 2 years
measure: Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria
timeFrame: Up to 2 years
measure: Incidence of short term grade III/IV/V toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
timeFrame: Up to 60 days post-surgery
measure: Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0
timeFrame: Up to 2 years
measure: Rate of flap complications (rate of flap revisions and flap complete revisions required)
timeFrame: Up to 2 years
measure: Expression of molecular markers
timeFrame: Up to 24 hours after initial radiation treatment
measure: Quantitative imaging characteristics in the pre-treatment PET/CT
timeFrame: Baseline
measure: Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter
timeFrame: Baseline to up to 2 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sung Kim
role: PRINCIPAL_INVESTIGATOR
References: