A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT01488838
• Date of registration: 07/12/2011
• Prospective Registration: No
• Primary sponsor: King Faisal Specialist Hospital & Research Center
• Public title: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
• Date of first enrolment: November 2011
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01488838
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Saudi Arabia

Key inclusion & exclusion criteria

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: 3.2.7.1 Unstable angina and/or congestive heart failure
requiring hospitalization within the last 6 months; 3.2.7.2 Transmural myocardial
infarction within the last 6 months; 3.2.7.3 Acute bacterial or fungal infection requiring
intravenous antibiotics at the time of registration; 3.2.7.4 Chronic Obstructive Pulmonary
Disease exacerbation or other respiratory illness requiring hospitalization or precluding
study therapy at the time of registration; 3.2.7.5 Hepatic insufficiency resulting in
clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are
not required for entry into this protocol. 3.2.7.6 Acquired Immune Deficiency Syndrome
(AIDS) 3.2.7.7 Pre-existing = grade 2 neuropathy; 3.2.7.8 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant Salivary Gland Tumors

Intervention(s)

Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions

Drug: Cisplatin: 40 mg/m2 weekly during radiation

Primary Outcome(s)

Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. [Time Frame: Two years]

Secondary ID(s)

2111-096

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Radiation Therapy Oncology Group