Location: New Programs :101640
|Program||Head & Neck, Oral Cavity, Thyroid|
|Diagnosis Region||Lip, Oral Cavity and Pharynx|
|Trial Type||Treatment (TRE)|
|Title||A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors|
|Primary Investigator||Joshua Hornig email@example.com|
|Study Coordinator||Kristina Woodruff 843-792-8795 firstname.lastname@example.org|
3.1.1 Pathologically proven diagnosis of a malignant major salivary gland tumor of the following
histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma or high
3.1.2 Surgical resection with curative intent within 8 weeks prior to registration;
3.1.3 Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically positive
surgical margin (AJCC, 7th ed.; see Appendix IV); patients must be free of distant metastases
based upon the following minimum diagnostic workup:
220.127.116.11 History/physical examination within 8 weeks prior to registration;
18.104.22.168 Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior
to registration; at a minimum, contrast CT imaging of the chest is required; PET/CT is
3.1.4 Zubrod Performance Status 0-1;
3.1.5 Age ≥ 18;
3.1.6 CBC/differential obtained within 4 weeks prior to registration, with adequate bone marrow
function defined as follows:
22.214.171.124 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
126.96.36.199 Platelets ≥ 100,000 cells/mm3;
188.8.131.52 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥
8.0 g/dl is acceptable.)
3.1.7 Adequate renal and hepatic function within 4 weeks prior to registration;, defined as follows:
184.108.40.206 Serum creatinine < 2.0 mg/dl;
220.127.116.11 Total bilirubin < 2 x the institutional ULN;
18.104.22.168 AST or ALT < 3 x the institutional ULN.
3.1.8 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing
3.1.9 Women of childbearing potential and male participants who are sexually active must practice
adequate contraception during treatment and for 6 weeks following treatment.
3.1.10 Patients must be deemed able to comply with the treatment plan and follow-up schedule.
3.1.11 Patients must provide study specific informed consent prior to study entry, including consent for
mandatory tissue submission for central review.
3.2.1 Patients with residual macroscopic disease after surgery;
3.2.2 Patients with salivary gland malignancies originating from the minor salivary glands;
3.2.3 Patients with histologies other than high grade mucoepidermoid carcinoma, high grade
adenocarcinoma or salivary duct carcinoma;
3.2.4 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
3.2.5 Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior
chemotherapy for a different cancer is allowable;
3.2.6 Prior radiotherapy to the region of the study cancer that would result in overlap of radiation
3.2.7 Severe, active co-morbidity, defined as follows:
22.214.171.124 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6
126.96.36.199 Transmural myocardial infarction within the last 6 months;
188.8.131.52 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
184.108.40.206 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring
hospitalization or precluding study therapy at the time of registration;
220.127.116.11 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however,
coagulation parameters are not required for entry into this protocol.
18.104.22.168 Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; 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.
22.214.171.124 Pre-existing ≥ grade 2 neuropathy;
126.96.36.199 Prior organ transplant.
3.2.8 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;
3.2.9 Significant pre-existing hearing loss, as defined by the patient or treating physician.
|Hypothesis||Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors;
Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. |
|Available Documents|| HIPAA |