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

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

Tracking Information

• First Submitted Date: December 7, 2017
• First Posted Date: December 12, 2017
• Last Update Posted Date: September 16, 2019
• Actual Study Start Date: February 25, 1991
• Actual Primary Completion Date: January 15, 1999 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: December 11, 2017): Survival time for the treatment versus control groups. [ Time Frame: 20 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Stage I-II Head and Neck Cancer

Intervention

• Drug: 13-cis retinoic acid
  Taken daily.
• Other: Placebo
  Placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2017): 189
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 14, 2015
• Actual Primary Completion Date: January 15, 1999 (Final data collection date for primary outcome measure)

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.

• Sex/Gender: Not Provided
• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03370367
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Eastern Cooperative Oncology Group
• Study Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Eastern Cooperative Oncology Group
• Verification Date: December 2017