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

NCT02295540 | Withdrawn

• 4 other identifiers: Pro20140000684NCI-2014-02215031401P30CA072720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Locoregional control

  Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.

  2 years

Secondary Outcomes (8)

• Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes

  Up to 2 years

• Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria

  Up to 2 years

• 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

  Up to 60 days post-surgery

• Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0

  Up to 2 years

• Rate of flap complications (rate of flap revisions and flap complete revisions required)

  Up to 2 years

Study Arms (1)

Treatment (hypofractionated IMRT, surgery)

EXPERIMENTAL

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

Radiation: hypofractionated radiation therapy; Radiation: intensity-modulated radiation therapy; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Interventions

hypofractionated radiation therapy RADIATION

Undergo hypofractionated IMRT

Treatment (hypofractionated IMRT, surgery)

intensity-modulated radiation therapy RADIATION

Undergo hypofractionated IMRT

Also known as: IMRT

Treatment (hypofractionated IMRT, surgery)

therapeutic conventional surgery PROCEDURE

Undergo surgery

Treatment (hypofractionated IMRT, surgery)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (hypofractionated IMRT, surgery)

Eligibility Criteria

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

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Tongue Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Sung Kim

  Rutgers Cancer Institute of New Jersey

  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: Residency Director

Model Details: Preoperative hypofractionated radiation followed by surgical resection

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: August 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)