Clinical trial NCT03370367: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage I-II Head and Neck Cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
First posted: 2017-12-12
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The time to diagnosis of second primary for the treatment versus control groups.
timeFrame: 20 years
Secondary outcomes:
measure: Survival time for the treatment versus control groups.
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References: