NCT00133887

Brief Summary

In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

6.9 years

First QC Date

August 23, 2005

Last Update Submit

December 19, 2025

Conditions

Skin CancerKidney Transplantation

Keywords

Squamous cell carcinomakidney transplant recipientsrapamycinSkin cancers in kidney transplant recipients

Outcome Measures

Primary Outcomes (1)

  • To assess the incidence of new squamous cell carcinoma in kidney transplant recipients

    during 5 years

Secondary Outcomes (3)

  • To assess the incidence of other non skin cancer in kidney transplant recipients

    during 5 years

  • To assess the graft survival

    during 5 years

  • To assess the tolerance of rapamycin

    during 5 years

Study Arms (2)

1

EXPERIMENTAL

patients receiving Rapamycin

Drug: rapamycin

2

ACTIVE COMPARATOR

patients receiving anticalcineurin treatment

Drug: ciclosporineDrug: tacrolimus

Interventions

ciclosporineDRUG

Blood residual level \< or = to 125 ng/ml

2
tacrolimusDRUG

Blood residual level \< or = to 8 ng/ml

2
rapamycinDRUG

3 to 5 mg/day

Also known as: Rapamune
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors

You may not qualify if:

  • Other squamous cell carcinomas in the past history
  • More than 2 transplantations
  • Patients not under calcineurin inhibitors
  • Unstable graft function
  • Non controlled hyperlipidemia (cholesterol \> 7.8 mmol/l or triglycerides \> 3.95 mmol/l)
  • Leucopenia \< 3000/mm3
  • Thrombocytopenia \< 100,000/mm3
  • Liver dysfunction
  • Pregnancy
  • Allergy to macrolides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot - Service de Dermatologie

Lyon, 69003, France

Location

Related Publications (4)

  • Dantal J, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, Del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra A, Hofbauer GFL, Kamar N, Pouteil-Noble C, Kanitakis J, Roux A, Decullier E, Euvrard S; TUMORAPA Study Group. Sirolimus for Secondary Prevention of Skin Cancer in Kidney Transplant Recipients: 5-Year Results. J Clin Oncol. 2018 Sep 1;36(25):2612-2620. doi: 10.1200/JCO.2017.76.6691. Epub 2018 Jul 17.

    PMID: 30016177RESULT

  • Euvrard S, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra AL, Hofbauer GF, Pouteil-Noble C, Campistol JM, Kanitakis J, Roux AS, Decullier E, Dantal J; TUMORAPA Study Group. Sirolimus and secondary skin-cancer prevention in kidney transplantation. N Engl J Med. 2012 Jul 26;367(4):329-39. doi: 10.1056/NEJMoa1204166.

    PMID: 22830463RESULT

  • Aractingi S, Kanitakis J, Euvrard S, Le Danff C, Peguillet I, Khosrotehrani K, Lantz O, Carosella ED. Skin carcinoma arising from donor cells in a kidney transplant recipient. Cancer Res. 2005 Mar 1;65(5):1755-60. doi: 10.1158/0008-5472.CAN-04-2783.

    PMID: 15753371RESULT

  • Martinez JC, Otley CC, Euvrard S, Arpey CJ, Stasko T; International Transplant-Skin Cancer Collaborative. Complications of systemic retinoid therapy in organ transplant recipients with squamous cell carcinoma. Dermatol Surg. 2004 Apr;30(4 Pt 2):662-6. doi: 10.1111/j.1524-4725.2004.30153.x.

    PMID: 15061852RESULT

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Squamous Cell

Interventions

SirolimusCyclosporinsTacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sylvie EUVRARD, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

April 1, 2004

Primary Completion

March 1, 2011

Study Completion

May 1, 2014

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

FR(1)