A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Mali...

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"If you have salivary gland cancer that is at-risk to return after surgery, this study will test treatment with chemotherapy and radiation."
Age: 18 to 80 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Malignant Salivary Gland Tumors, tumor
Type: Drug study, Phase 2
Target:
6 Participants
Investigator:
Description
You are being asked to take part in this study because you have cancer of the salivary gland. Your cancer is at high risk to come back after surgery.

The standard treatment for cancer of the salivary gland is surgery. All patients will have had surgery before taking part in this study. Although the surgery may have removed your cancer, features of your disease suggest that you are at an increased risk for your cancer to return.

Patients at risk for disease return after surgery usually receive radiation therapy to the head and neck after surgery. The purpose of this study is to test the use of chemotherapy with radiation. The study team wants to know if combining this treatment is better than radiation alone.

The study will compare the good and bad effects on you and your salivary gland cancer. We want to know which is better at reducing the chance that your cancer will come back.
This study requires

If you agree to take part in this study, your study doctor will send some of your tumor tissue to a central office to confirm your type of tumor. The tissue will be obtained during your surgery and having it tested is required for this study.

Eligible participants will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in either group.

If you are in Group 1 (often called "Arm 1"), you will receive radiation therapy once a day, Monday through Friday for about 6 to 7 weeks. Each treatment may take up to 30 minutes depending on the technique used. You will also receive a chemotherapy drug, cisplatin, through the vein, every week (before or after radiation). You will receive a total of 7 treatments. Chemotherapy will take about 4 hours. This includes administering medications to prevent nausea and to replace body fluids.

If you are in Group 2 (often called "Arm 2"), you will receive radiation therapy once a day, Monday through Friday for about 6 to 7 weeks. Each treatment may take up to 30 minutes depending on the technique used.

Who can participate

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
  • Age ≥ 18
  • 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
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
  • Patients must be deemed able to comply with the treatment plan and follow-up schedule.

Exclusion criteria:

  • Patients with residual macroscopic disease after surgery
  • Patients with salivary gland malignancies originating from the minor salivary glands
  • 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)
  • Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable
  • 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; - 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
  • 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.
  • 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
  • Significant pre-existing hearing loss, as defined by the patient or treating physician.
Benefits and risks of participating
BENEFITS:

We cannot perms any benefits to you as a result of taking part in this research study.

RISKS:

The study doctor will discuss the benefits and risks associated with taking part in this research study.
Compensation
You will not be paid for taking part in this study.
Resources
Schedule
Study duration and period
You will receive radiation therapy with or without chemotherapy for 6 to 7 weeks. You will be seen in a follow-up visit at 3 months following radiation therapy. Then you will be seen at 6, 9, 12, 18, and 24 months from the start of radiation for years 1 and 2, every 6 months for years 3 and 4, and then yearly for your lifetime.
Recruitment period
From April 25, 2017
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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