Skin CancerPhase 3NCT00133887
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
A Phase 3 study testing rapamycin, ciclosporine and tacrolimus in people with Skin Cancer and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin Cancer, Kidney Transplantation
- What is being tested?
- rapamycin, ciclosporine and tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2004to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
Who cannot join
- 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
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- Thrombocytopenia < 100,000/mm3
- Liver dysfunction
- Pregnancy
- Allergy to macrolides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors
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.
- Conditions
- Skin Cancer, Kidney Transplantation
- Being tested
- rapamycin, ciclosporine, tacrolimus
- Keywords
- Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients
- Medical subject headings
- Skin Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapamycinDrug
Also called Rapamune
3 to 5 mg/day
ciclosporineDrug
Blood residual level < or = to 125 ng/ml
tacrolimusDrug
Blood residual level < or = to 8 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients receiving Rapamycin Receives: Drug: rapamycin |
| 2 | Active comparator | patients receiving anticalcineurin treatment Receives: Drug: ciclosporine; Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
Measured: during 5 years
Secondary outcomes (3)
To assess the incidence of other non skin cancer in kidney transplant recipients
Measured: during 5 years
To assess the graft survival
Measured: during 5 years
To assess the tolerance of rapamycin
Measured: during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionMar 2011
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie EUVRARD, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133887
- Sponsor's protocol ID
- 2003.333
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2005
- Last updated
- 26 Dec 2025
- Results posted
- No
Publications
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.
PubMed 30016177Euvrard 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.
PubMed 22830463Aractingi 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.
PubMed 15753371Martinez 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.
PubMed 15061852
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors
- ClinicalTrials.gov ID
- NCT00133887
- Acronym / sponsor ID
- 2003.333
- Conditions
- Skin Cancer, Kidney Transplantation
- Keywords
- Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rapamycinpatients receiving Rapamycin |
| 2 | Active comparator | Drug: ciclosporine, Drug: tacrolimuspatients receiving anticalcineurin treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapamycinAlso: Rapamune3 to 5 mg/day | Drug | 1 |
| ciclosporineBlood residual level < or = to 125 ng/ml | Drug | 2 |
| tacrolimusBlood residual level < or = to 8 ng/ml | Drug | 2 |
Primary outcome
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
Time frame: during 5 years
3 secondary outcomes
To assess the incidence of other non skin cancer in kidney transplant recipients
Time frame: during 5 years
To assess the graft survival
Time frame: during 5 years
To assess the tolerance of rapamycin
Time frame: during 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 30016177Dantal 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.
- Results publication: PubMed 22830463Euvrard 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.
- Results publication: PubMed 15753371Aractingi 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.
- Results publication: PubMed 15061852Martinez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie EUVRARD, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rapamycin, ciclosporine and tacrolimus in people with Skin Cancer and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients (time frame: during 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133887, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.