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

Tongue Cancer Clinical Trial

Official title:

Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02295540
• Other study ID #: Pro20140000684
• Secondary ID: NCI-2014-0221503
• Status: Withdrawn
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2020

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• 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
• Tongue Neoplasms

Intervention

Radiation:
• hypofractionated radiation therapy
Undergo hypofractionated IMRT
• intensity-modulated radiation therapy
Undergo hypofractionated IMRT

Procedure:
• therapeutic conventional surgery
Undergo surgery

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	New Jersey Medical School	Newark	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control	Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.	2 years
Secondary	Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes		Up to 2 years
Secondary	Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria	CT neck with IV contrast will be performed before and after radiation therapy.	Up to 2 years
Secondary	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	Interim analysis will be used for grade IV toxicity (death).	Up to 60 days post-surgery
Secondary	Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0		Up to 2 years
Secondary	Rate of flap complications (rate of flap revisions and flap complete revisions required)		Up to 2 years
Secondary	Expression of molecular markers	Will correlate molecular markers (especially those relating to radioresitance such as B-cell lymphoma 2 or autophagy markers to locoregional control).	Up to 24 hours after initial radiation treatment
Secondary	Quantitative imaging characteristics in the pre-treatment PET/CT	Includes max/peak/total/mean standard uptake value, the metabolic tumor volume, and the total lesion glycolysis. These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.	Baseline
Secondary	Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter	These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.	Baseline to up to 2 years