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Phase 2
18 Years
80 Years
Open (Enrolling)
Malignant Salivary Gland Tumors

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Trial Information

Inclusion Criteria:

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 grade adenocarcinoma;

2. Surgical resection with curative intent within 8 weeks prior to registration;

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:

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 3.1.7 Adequate
renal and hepatic function within 4 weeks prior to registration 3.1.8 Negative serum
pregnancy test within 2 weeks prior to registration for women of childbearing
potential; 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.

Exclusion Criteria:

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 permissible); 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 therapy fields; 3.2.7 Severe, active
co-morbidity, defined as follows: 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 at the time of registration; Hepatic insufficiency resulting in
clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are
not required for entry into this protocol. Acquired Immune Deficiency Syndrome
(AIDS) Pre-existing ≥ grade 2 neuropathy; 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; 3.2.9 Significant pre-existing hearing loss, as defined by the patient or
treating physician.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Outcome Time Frame:

Two years

Safety Issue:



Saudi Arabia: Ethics Committee

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Malignant Salivary Gland Tumors
  • Salivary Gland Neoplasms