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CSP #402 - VA Topical Tretinoin Chemoprevention Trial


Phase 3
N/A
N/A
Not Enrolling
Both
Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms

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Trial Information

CSP #402 - VA Topical Tretinoin Chemoprevention Trial


Primary Hypothesis: To determine the efficacy of topical tretinoin cream for the
prevention of nonmelanoma skin cancer (NMSC) among high risk individuals (at least 2 NMSC?S
in last 5 years).

Secondary Hypothesis: Secondary objectives are: (a) to determine the long-term effect of
topical tretinoin on the prevalence of premalignant actinic keratoses, and (b) to
distinguish subpopulations in which topical tretinoin is particularly effective or
ineffective, compared to the overall study population.

Intervention: Apply Tretinoin 0.1% cream or placebo cream to face and ears twice a day.

Primary Outcomes: New NMSC lesions on the face and ears. Number of actinic keratoses on
the face and ears.

Study Abstract: One-third of all malignancies in the United States (approximately one
million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes
considerable morbidity, economic burden, facial deformity and at least 1,000 deaths
annually. Prevention of these malignancies with a topical agent free of serious side
effects would confer substantial public health benefit. Three hundred fifty thousand
veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions
requiring dermatologic care in the VA system.

Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered
orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer
but have unacceptable toxicity. In this study, 1200 patients with a recent history of
squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over
a four-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo.
They will be followed for a minimum of two years to determine if topical tretinoin is
effective in reducing the risk of new occurrences.

Weinstock, M.A., Bingham, S.F., Cole, G.W., Eilers, D., Naylor, M.F., Kalivas, J., Taylor,
J.R., Gladstone, H.B., Piacquadio, D.J., and DiGiovanna, J.J. Reliability of Counting
Actinic Keratoses Before and After Brief Consensus Discussion. Arch Dermatol 137:1055-1058,
2001


Inclusion Criteria:



High risk individuals (at least 2 NMSC?S in last 5 years).

Exclusion Criteria:

Exclusion criteria would include systemic retinoid treatment or systemic chemotherapy
within the past six months; indices of very high mortality risk within 3 years (history of
invasive noncutaneous malignancy within the past five years or metastatic cutaneous
malignancy, or of other severe medical problems e.g. end-stage cardiac disease); known
allergy or severe irritation reaction to tretinoin or the cream vehicle; special
conditions predisposing to NMSC that may not be generally applicable (xeroderma
pigmentosum, basal cell nevus syndrome, major organ transplant recipient, known arsenic
exposure, PUVA photochemotherapy, mycosis fungoides, or prior or current radiation therapy
involving the face, ears, or area of prior skin cancer), and likely inability to comply
with the requirements of the trial as judged by the investigator. Incompetent patients
and pregnant or nursing patients will be excluded

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Long term effect of topical tretinoin on the prevalence of premalignant actinic keratoses

Outcome Time Frame:

until the end of the study for a minimum of 2 years

Safety Issue:

No

Principal Investigator

Martin A. Weinstock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

VA Medical Center, Providence

Authority:

United States: Federal Government

Study ID:

402

NCT ID:

NCT00007631

Start Date:

March 1998

Completion Date:

July 2006

Related Keywords:

  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Skin Neoplasms
  • NMSC
  • nonmelanoma skin cancer
  • topical tretinoin cream
  • Neoplasms
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Basosquamous

Name

Location
VA Medical Center, Durham Durham, North Carolina  27705
Carl T. Hayden VA Medical Center Phoenix, Arizona  85012
VA Medical Center, Long Beach Long Beach, California  90822
VA Medical Center, Miami Miami, Florida  33125
Edward Hines, Jr. VA Hospital Hines, Illinois  60141-5000
VA Medical Center, Oklahoma City Oklahoma City, Oklahoma  73104
VA Medical Center, Providence Providence, Rhode Island  02908