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

A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors

Study Overview

• Status: Completed
• Conditions: Malignant Salivary Gland Tumors
• Intervention / Treatment: Drug: Cisplatin: 40 mg/m2 weekly during radiation; Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital& Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Radiation: 60-66 Gy in 2 Gy daily fractions Cisplatin: 40 mg/m2 weekly during radiation for 7 doses	Drug: Cisplatin: 40 mg/m2 weekly during radiation; Cisplatin: 40 mg/m2 weekly during radiation for 7 doses
Active Comparator: Arm 2: Radiation: 60-66 Gy in 2 Gy daily fractions	Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions; Radiation: 60-66 Gy in 2 Gy daily fractions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Collaborators: Radiation Therapy Oncology Group

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Salivary Gland Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: 2111-096