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©2022 Stanford Medicine
Trial ID: NCT01302834
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell
carcinoma (including the histological variants papillary squamous cell carcinoma and
basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft
palate, or oropharyngeal walls).
2. Patients must be positive for p16, determined by central review prior to
3. Patients must have clinically or radiographically evident measurable disease at the
primary site or at nodal stations. Tonsillectomy or local excision of the primary
without removal of nodal disease is permitted, as is excision removing gross nodal
disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes
are permitted and considered as non-therapeutic nodal excisions. Fine needle
aspirations of the neck are insufficient due to limited tissue for retrospective
central review. Biopsy specimens from the primary or nodes measuring at least 3-5 mm
4. Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III),
including no distant metastases, based upon the following minimum diagnostic workup:
- General history and physical examination by a radiation oncologist and medical
oncologist within 8 weeks prior to registration;
- Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including
laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8
weeks prior to registration;
- One of the following combinations of imaging is required within 8 weeks prior to
1. A computerized tomography (CT) scan of the neck (with contrast) and a chest
CT scan (with or without contrast);
2. or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a
chest CT scan (with or without contrast);
3. or a CT scan of neck (with contrast) and a positron emission tomography
(PET)/CT of neck and chest (with or without contrast);
4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with
or without contrast).
Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a
radiologist may serve as both staging and planning tools.
5. Zubrod Performance Status 0-1 within 2 weeks prior to registration
6. Age ≥ 18;
7. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration
on study, with adequate bone marrow function, defined as follows:
- Absolute neutrophil count (ANC) > 1,500 cells/mm3;
- Platelets > 100,000 cells/mm3;
- Hemoglobin (Hgb) > 8.0 g/dl; Note: The use of transfusion or other intervention
to achieve Hgb > 8.0 g/dl is acceptable.
8. Adequate hepatic function, defined as follows:
- Bilirubin < 2 mg/dl within 2 weeks prior to registration;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the
upper limit of normal within 2 weeks prior to registration;
9. Adequate renal function, defined as follows:
• Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration or creatinine
clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour
collection or estimated by Cockcroft-Gault formula:
CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x
10. Patients must provide their smoking history (for stratification) via the
computer-assisted self interview (CASI) head and neck risk factor survey tool.
11. Negative serum pregnancy test within 2 weeks prior to registration for women of
12. Women of childbearing potential and male participants must agree to use a medically
effective means of birth control throughout their participation in the treatment phase
of the study and until at least 60 days following the last study treatment.
13. Patients who are human immunodeficiency virus (HIV) positive but have no prior
acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at
least 350/mm3 are eligible. Patient HIV status must be known prior to registration.
Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen
positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C
(anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B
(anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized
against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV
infection or other concurrent AIDS-defining conditions.
14. Patient must provide study specific informed consent prior to study entry, including
consent for mandatory submission of tissue for required, central p16 review and
consent to participate in the computer-assisted self interview (CASI) survey questions
regarding smoking history.
1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar
ridge, buccal or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive, are
excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive)
are excluded from participation.
2. Stage T1-2, N0-1;
3. Distant metastasis or adenopathy below the clavicles;
4. Gross total excision of both primary and nodal disease; this includes tonsillectomy,
local excision of primary site, and nodal excision that removes all clinically and
radiographically evident disease.
5. Simultaneous primaries or bilateral tumors;
6. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible);
7. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable;
8. Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields;
9. Severe, active co-morbidity, defined as follows:
- 9.1 Unstable angina and/or congestive heart failure requiring hospitalization
within the last 6 months;
- 9.2 Transmural myocardial infarction within the last 6 months;
- 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration;
- 9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory
illness requiring hospitalization or precluding study therapy within 30 days of
- 9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation
defects; note, however, that laboratory tests for liver function and coagulation
parameters are not required for entry into this protocol.
- 9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for
Disease Control and Prevention (CDC) definition with immune compromise greater
than that noted in Section 3.1.13; note, however, that 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.
10. 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
11. Prior allergic reaction to cisplatin or cetuximab;
12. Prior cetuximab or other anti-EGFR therapy.
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