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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma of the Head and Neck Drug: All-trans Retinoic Acid Drug: VEGFR inhibitor Drug: Chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 3, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Tretinoin

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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).
 Drug: VEGFR inhibitor
VEGFR inhibitor

Drug: Chemotherapy
chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04433169


Contacts
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Contact: Guopei Zhu, M.D 021-23271699 ext 5665 antica@gmail.com

Locations
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China, Shanghai
Shanghai Ninth People's Hospital Recruiting
Shanghai, Shanghai, China, 200011
Contact: Lulu Ye, Master    021-23271699 ext 5665    yee166@163.com   
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04433169    
Other Study ID Numbers: 2020HNRT02
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents