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Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370367
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 12, 2017
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE February 25, 1991
Actual Primary Completion Date January 15, 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
The time to diagnosis of second primary for the treatment versus control groups. [ Time Frame: 20 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03370367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
Survival time for the treatment versus control groups. [ Time Frame: 20 years ]
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 Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer
Official Title  ICMJE Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer
Brief Summary

In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include:

  1. The time to diagnosis of second primary for the treatment versus control groups.
  2. Survival time for the treatment versus control groups.
  3. Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Stage I-II Head and Neck Cancer
Intervention  ICMJE
  • Drug: 13-cis retinoic acid
    Taken daily.
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Arm A
    13-cis retinoic acid will be dispensed in 3.75 mg and 5 mg gelatin capsules. Take 2 capsules once a day for up to 2 years.
    Intervention: Drug: 13-cis retinoic acid
  • Placebo Comparator: Arm B
    Take 2 placebo pills once a day for up to 2 years.
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2017)
189
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 14, 2015
Actual Primary Completion Date January 15, 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent i obtained, the approved form is signed, and on file at the institution.
  • Histologically confirmed squamous cell carcinoma.
  • All chest x-rays and cervical spine x-rays done after definitive treatment within 35 days prior to randomization and all hematology andchemistries done within 2 weeks prior to randomization.
  • The following sites and stages of cancers will be eligible. Oral Cavity

    1. T1 NO
    2. T2 NO 3.142 Oropharynx
    1. T1 NO
    2. T2 NO 3.143 Hypopharynx

    1. T1 NO 3.144 Larynx

    1. T1 NO
    2. T2 NO
  • Age greater than 18 years.
  • ECOG performance status 0 or 1.
  • Patients must have adequate bone marrow, hepatic and renal function defined as follows: WBC >3,500/mm, Platelets > 125,000/mm.3 Total Bilirubin < 2 mg%, Serum creatinine < 2.5 mg%. Serum SGOT < 2x normal, Alkaline Phosphatase < 2x normal. Fasting Serum triglyceride levels < 210 mg %. Fasting cholesterol < 350 mg %. Patient may not be under systemic therapy for hyperlipidemia or have symptomatic arteriosclerotic coronary artery disease or have undergone coronary bypass surgery.
  • The patient must have completed primary treatment of their cancer with surgery and/or radiation therapy within 730 days prior to randomization.
  • The patient has had surgery and/or radiation therapy as outlined in Sections 5.0 and 6.0, and has been rendered disease-free.
  • If currently receiving, patient must discontinue mega vitamin doses

Exclusion Criteria:

  • Women of child bearing potential.
  • Patient with severe coronary artery disease (Class III-IV New York Heart Association.)
  • Histology other than squamous cell carcinoma.
  • Distant metastases.
  • Completion of previous treatment for their primary cancer with radiation, or surgery (except for biopsy) more than 730 days ago.
  • Prior, synchronous, or concurrent malignancy except basal cell skin cancer.
  • Failure to be rendered disease-free of primary tumor (includes positive surgical margins).
  • The patient has had prior therapy other than that outlined in Sections 5.0 and 6.0 of the protocol.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03370367
Other Study ID Numbers  ICMJE C0590
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eastern Cooperative Oncology Group
Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eastern Cooperative Oncology Group
Verification Date December 2017

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