NCT03370367

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. 1.The time to diagnosis of second primary for the treatment versus control groups.
  2. 2.Survival time for the treatment versus control groups.
  3. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 1989

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 1989

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 1999

Completed
16.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

9.7 years

First QC Date

December 7, 2017

Last Update Submit

June 13, 2023

Conditions

Stage I-II Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • The time to diagnosis of second primary for the treatment versus control groups.

    20 years

Secondary Outcomes (1)

  • Survival time for the treatment versus control groups.

    20 years

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

PLACEBO COMPARATOR

Take 2 placebo pills once a day for up to 2 years.

Other: Placebo

Interventions

13-cis retinoic acidDRUG

Taken daily.

Arm A
PlaceboOTHER

Placebo

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • T1 NO
  • T2 NO 3.142 Oropharynx
  • <!-- -->
  • T1 NO
  • T2 NO 3.143 Hypopharynx
  • \. T1 NO 3.144 Larynx
  • T1 NO
  • 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.
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

May 15, 1989

Primary Completion

January 15, 1999

Study Completion

April 14, 2015

Last Updated

June 15, 2023

Record last verified: 2023-06