A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
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ClinicalTrials.gov Identifier: NCT01488838 |
Recruitment Status
:
Completed
First Posted
: December 8, 2011
Last Update Posted
: February 25, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Salivary Gland Tumors | Drug: Cisplatin: 40 mg/m2 weekly during radiation Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
- Surgical resection with curative intent within 8 weeks prior to registration;
- 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488838
Saudi Arabia | |
King Faisal Specialist Hospital& Research Center | |
Riyadh, Saudi Arabia, 11211 |
Responsible Party: | King Faisal Specialist Hospital & Research Center |
ClinicalTrials.gov Identifier: | NCT01488838 History of Changes |
Other Study ID Numbers: |
2111-096 |
First Posted: | December 8, 2011 Key Record Dates |
Last Update Posted: | February 25, 2016 |
Last Verified: | December 2011 |
Additional relevant MeSH terms:
Salivary Gland Neoplasms Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Cisplatin Antineoplastic Agents |