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

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ClinicalTrials.gov Identifier: NCT02295540
Recruitment Status : Withdrawn (slow accrual)
First Posted : November 20, 2014
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Sung Kim, MD, Residency and Clinical Director, Rutgers Cancer Institute of New Jersey

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.

Condition or disease Intervention/treatment Phase
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 Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Preoperative hypofractionated radiation followed by surgical resection
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
Study Start Date : August 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (hypofractionated IMRT, surgery)
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
Undergo hypofractionated IMRT

Radiation: intensity-modulated radiation therapy
Undergo hypofractionated IMRT
Other Name: IMRT

Procedure: therapeutic conventional surgery
Undergo surgery

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Locoregional control [ Time Frame: 2 years ]
    Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.


Secondary Outcome Measures :
  1. Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes [ Time Frame: Up to 2 years ]
  2. Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria [ Time Frame: Up to 2 years ]
    CT neck with IV contrast will be performed before and after radiation therapy.

  3. 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 [ Time Frame: Up to 60 days post-surgery ]
    Interim analysis will be used for grade IV toxicity (death).

  4. Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0 [ Time Frame: Up to 2 years ]
  5. Rate of flap complications (rate of flap revisions and flap complete revisions required) [ Time Frame: Up to 2 years ]
  6. Expression of molecular markers [ Time Frame: Up to 24 hours after initial radiation treatment ]
    Will correlate molecular markers (especially those relating to radioresitance such as B-cell lymphoma 2 or autophagy markers to locoregional control).

  7. Quantitative imaging characteristics in the pre-treatment PET/CT [ Time Frame: Baseline ]
    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.

  8. Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter [ Time Frame: Baseline to up to 2 years ]
    These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295540


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Sung Kim Rutgers Cancer Institute of New Jersey

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Responsible Party: Sung Kim, MD, Residency and Clinical Director, Residency Director, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT02295540     History of Changes
Other Study ID Numbers: 031401
NCI-2014-02215 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
031401 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases