Back to resultsDouble 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
Primary Purpose
Stage I-II Head and Neck Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
13-cis retinoic acid
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Stage I-II Head and Neck Cancer
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
- T1 NO
- T2 NO 3.142 Oropharynx
- T1 NO
- T2 NO 3.143 Hypopharynx
1. 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A
Arm B
Arm Description
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.
Take 2 placebo pills once a day for up to 2 years.
Outcomes
Primary Outcome Measures
The time to diagnosis of second primary for the treatment versus control groups.
Secondary Outcome Measures
Survival time for the treatment versus control groups.
Full Information
NCT ID
NCT03370367
First Posted
December 7, 2017
Last Updated
June 13, 2023
Sponsor
Eastern Cooperative Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT03370367
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 1989 (Actual)
Primary Completion Date
January 15, 1999 (Actual)
Study Completion Date
April 14, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Cooperative Oncology Group
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
The time to diagnosis of second primary for the treatment versus control groups.
Survival time for the treatment versus control groups.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I-II Head and Neck Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Take 2 placebo pills once a day for up to 2 years.
Intervention Type
Drug
Intervention Name(s)
13-cis retinoic acid
Intervention Description
Taken daily.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The time to diagnosis of second primary for the treatment versus control groups.
Time Frame
20 years
Secondary Outcome Measure Information:
Title
Survival time for the treatment versus control groups.
Time Frame
20 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
T1 NO
T2 NO 3.142 Oropharynx
T1 NO
T2 NO 3.143 Hypopharynx
1. 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.
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.
12. IPD Sharing Statement
Links:
URL
https://nctn-data-archive.nci.nih.gov/
Description
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Learn more about this trial
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
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