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Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
|North Coast Cancer
Randomized Phase II Component Primary Objective
Phase III Component Primary Objective
- To select the better experimental arm to improve disease-free survival (DFS) over the control armof radiation and cisplatin
Randomized Phase II and Phase III Components Secondary Objectives
- To determine whether the selected experimental arm will improve overall survival (OS) over thecontrol arm of radiation and cisplatin
- To improve local-regional disease control;
- To compare distant metastasis;
- To compare patterns of cancer failure (local, regional, distant) and correlate with radiation doseand technique;
- To compare acute toxicity profiles during RT and at completion of treatment;
- To compare late toxicity profiles at 1, 3, and 5 years after treatment;
- To compare overall quality of life;
- To compare patient-reported outcome;
- To compare swallowing function at 1 and 2 years;
- To investigate associations between acute mucosal toxicity, swallowing function, and QOL;
- To compare quality adjusted life years (QALY);
- To investigate associations between late toxicity (dysphagia) and QALY;
- To determine whether specific molecular profiles are associated with clinical outcomes.
- Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx;
- Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration. Note: Patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection. The gross total resection has to be done within 63 days prior to registration. If, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible.
- Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink).
- Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:
Zubrod Performance Status of 0-1 within 14 days prior to registration;Age ≥ 18;CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
- General history and physical examination by a Radiation Oncologist and/or Medical Oncologist within 84 days prior to registration;
- Examination by an ENT or Head & Neck Surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure), if appropriate, is recommended but not required. Intra-operative examination is acceptable documentation.
- Pre-op Imaging of the head and neck: A neck CT (with contrast) or CT/PET (with contrast) and/or an MRI of the neck (T1 with Gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in DICOM format via TRIAD.The report is to be uploaded into Rave; see Section 11.2.
- Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: If the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement.
Adequate hepatic function, defined as follows:
- Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3;
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
Adequate renal function, defined as follows:
- Total bilirubin < 2 x institutional ULN within 14 days prior to registration;
- AST or ALT < 3 x institutional ULN within 14 days prior to registration.
Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential;The following assessments are required within 14 days prior to registration: Na, K, Cl, glucose, Ca, Mg, and albumin. Note: Patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.Patients with feeding tubes are eligible for the study.Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR analysis and for oropharyngeal cancer patients, HPV analysis.
- Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) ≥ 50 ml/min within 14 days 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 (CrCl male)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days [3 years]; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago;
- Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible.
- Prior systemic chemotherapy or anti-EGF therapy 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:
Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):
- Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration;
- Transmural myocardial infarction within 6 months prior to registration;
- 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 at the time of registration;
- Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note: 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 cetuximab.
- Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels;
- Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L);
- Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels;
- Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels;
- Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels.
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