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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: Locoregional control [ Time Frame: 2 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes [ Time Frame: Up to 2 years ]
  • 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.
  • 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).
  • Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0 [ Time Frame: Up to 2 years ]
  • Rate of flap complications (rate of flap revisions and flap complete revisions required) [ Time Frame: Up to 2 years ]
  • 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).
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: November 17, 2014
Date Started: August 2016
Date Completion: January 2020
Last Updated: January 19, 2017
Last Verified: January 2017