Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck (Aplus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04433169
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Tracking Information
First Submitted Date  ICMJE June 12, 2020
First Posted Date  ICMJE June 16, 2020
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE June 3, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
Objective Response Rate (CR+PR) [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • Number of Participants With at Least One Grade 3-4 Toxicity [ Time Frame: 6 months ]
    Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
  • Progression-Free Survival [ Time Frame: 6 months ]
    Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Official Title  ICMJE A Prospective, Open-label, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of All-trans Retinoic Acid (ATRA) in the Treatment of Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenoid Cystic Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: All-trans Retinoic Acid
    ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
    Other Name: Ailike
  • Drug: VEGFR inhibitor
    VEGFR inhibitor
  • Drug: Chemotherapy
    chemotherapy
Study Arms  ICMJE
  • Experimental: Experimental group
    ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.
    Intervention: Drug: All-trans Retinoic Acid
  • Active Comparator: Control group
    The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
    Interventions:
    • Drug: VEGFR inhibitor
    • Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Age ≥ 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3. Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with measurable disease (≥10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria below:

  1. Criteria for routine blood test: (no blood transfusion within 14 days)

    1. HB ≥ 90 g/L;
    2. WBC ≥ 3.5 × 109/L and < 10 × 109/L;
    3. ANC ≥ 1.5 × 109/L;
    4. PLT ≥ 80 × 109/L
  2. Criteria for biochemical tests:

    1. BIL < 1.25 × upper limit of normal (ULN)
    2. ALT and AST < 2.5 × ULN; in the presence of metastases to liver, ALT and AST < 5 × ULN;
    3. Serum Cr ≤ 1 × ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault equation); 5. Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. Patients who, in the doctor's opinion, can benefit from the treatment.

Exclusion Criteria:

  1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
  2. Coagulation abnormal (INR>1.5, APTT>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency [e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months];
  3. Confirmed hypersensitivity to ATRA;
  4. Grade I and above coronary artery diseases, arrhythmias [including QTc prolongation (males: > 450 ms, females: > 470 ms)] and cardiac dysfunction;
  5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
  6. Pregnant or lactating women;
  7. History of psychotropic abuse with abstinence failure, or existing mental disorder;
  8. Participation in other drug clinical trials within 4 weeks;
  9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guopei Zhu, M.D 021-23271699 ext 5665 antica@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04433169
Other Study ID Numbers  ICMJE 2020HNRT02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor  ICMJE Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP