This is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
VEGFR inhibitor
chemotherapy
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate (CR+PR)
Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: 6 months
Number of Participants With at Least One Grade 3-4 Toxicity
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: 6 months
Progression-Free Survival
Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.
Time frame: 6 months
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