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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. Identifier: NCT03370367
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment Phase
Stage I-II Head and Neck Cancer Drug: 13-cis retinoic acid Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 25, 1991
Actual Primary Completion Date : January 15, 1999
Actual Study Completion Date : April 14, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: 13-cis retinoic acid
Taken daily.

Placebo Comparator: Arm B
Take 2 placebo pills once a day for up to 2 years.
Other: Placebo

Primary Outcome Measures :
  1. The time to diagnosis of second primary for the treatment versus control groups. [ Time Frame: 20 years ]

Secondary Outcome Measures :
  1. Survival time for the treatment versus control groups. [ Time Frame: 20 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)

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.
Additional Information:
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Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT03370367    
Other Study ID Numbers: C0590
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: December 2017

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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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents