Overview

Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer

Status:
Withdrawn
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Treatments:
Cisplatin
Criteria
Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of squamous cell
carcinoma of the oropharynx, localized to the tonsil, glossopharyngeal sulcus, and
tongue-base within 6 weeks (42 days) of registration

- The primary tumor must be resectable through a transoral endoscopic head and neck
surgery with anticipation of resection free margins (resection does not require total
or subtotal glossectomy or total laryngectomy); specifically, patients must (1) not
have trismus, (2) not have interincisor opening less than 2.5 cm, and (3) not have
poor transoral exposure of the tumor itself nor surrounding soft-tissue margins,
regardless of etiology

- Clinical stage III-IV; T1-2, N1-2b; T3, N0-2b, with only well-lateralized exophytic T3
tumors not approaching within 1 cm of midline, and amenable to transoral eHNS

- p16 protein (p16) negative by immunohistochemistry (documented by the institution's
pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments
[CLIA]-certified lab), defined as absent, weak, and/or only focal nuclear and
cytoplasmic staining in less than 70% of the tumor cells

- Appropriate stage for protocol entry, including no distant metastases or adenopathy
below the clavicles, based upon the following minimum diagnostic workup:

- History/physical examination by the treating physician (radiation oncologist,
medical oncologist, or head and neck surgeon) within 30 days prior to
registration

- Imaging of the head and neck (CT with contrast, positron emission tomography
[PET]/CT, and/or magnetic resonance imaging [MRI]) within 30 days prior to
registration; a CT scan with contrast is mandatory (unless contraindicated, e.g.
contrast allergy, etc.); note that a PET/CT scan alone (unless performed with
contrast) is not sufficient

- Chest CT scan (with or without contrast) or PET/CT of chest (with or without
contrast) within 30 days prior to registration

- Modified barium swallow (MBS) to assess swallowing function within 30 days prior
to registration

- Preoperative Mallampati assessment as documented by attending surgeon within 30
days prior to registration

- Zubrod performance status 0-1 within 30 days prior to registration

- Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 based upon complete blood count
(CBC)/differential

- Platelets >= 100,000 cells/mm^3 based upon CBC/differential

- Hemoglobin >= 8.0 g/dl based upon CBC/differential (Note: The use of transfusion or
other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

- Total bilirubin =< 2 mg/dl

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper
limit of normal

- Serum creatinine =< 1.5 mg/dl and/or creatinine clearance (CC) >= 50 ml/min; CC can be
determined by 24-hour collection or estimated by Cockcroft-Gault formula

- Serum pregnancy test within 14 days prior to registration for women of childbearing
potential

- Women of childbearing potential and male participants who are sexually active must
practice medically effective contraception during treatment and for 42 days following
completion of treatment

- Patient must be able to provide study-specific informed consent prior to study entry

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast or
cervix are all permissible)

- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable

- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields

- Severe, active co-morbidity, defined as follows:

- > 2 based on the American Society of Anesthesiologists (ASA) physical status
classification system

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days before
registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
Control (CDC) definition; note, however, that human immunodeficiency virus (HIV)
testing is not required for entry into this protocol; the need to exclude
patients with AIDS from this protocol is necessary because the treatments
involved in this protocol may be significantly immunosuppressive;
protocol-specific requirements may also exclude immuno-compromised patients

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the treatment involved in this study may be significantly
teratogenic

- Prior allergic reaction to cisplatin

- Radiographic evidence of retropharyngeal metastasis