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TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

NCT ID: NCT00133887

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer Kidney Transplantation

Keywords

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Squamous cell carcinoma kidney transplant recipients rapamycin Skin cancers in kidney transplant recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

patients receiving Rapamycin

Group Type EXPERIMENTAL

rapamycin

Intervention Type DRUG

3 to 5 mg/day

2

patients receiving anticalcineurin treatment

Group Type ACTIVE_COMPARATOR

ciclosporine

Intervention Type DRUG

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

tacrolimus

Intervention Type DRUG

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

Interventions

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rapamycin

3 to 5 mg/day

Intervention Type DRUG

ciclosporine

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

Intervention Type DRUG

tacrolimus

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

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie EUVRARD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edouard Herriot - Service de Dermatologie

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30016177 (View on PubMed)

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.

Reference Type RESULT
PMID: 22830463 (View on PubMed)

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.

Reference Type RESULT
PMID: 15753371 (View on PubMed)

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.

Reference Type RESULT
PMID: 15061852 (View on PubMed)

Other Identifiers

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2003.333

Identifier Type: -

Identifier Source: org_study_id