Uveal MelanomaPhase 3FOTEADJNCT02843386
Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma
A Phase 3 study testing Adjuvant chemotherapy by Fotemustin and Intensive surveillance in people with Uveal Melanoma, run by Institut Curie at 6 sites in 2 countries.
Trial summary
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between: Adjuvant chemotherapy with Fotemustin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Adjuvant chemotherapy by Fotemustin and Intensive surveillance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 23 Jun 2009to 12 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk uveal melanoma, defined by :
- Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extrascleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/OR
- Genomic high risk signature (cCGH +/- LOH) : Monosomy 3 or partial deletion of 3p and any 8 gain, from enucleation, transscleral or transvitreal samples
- Age ≥ 18 years and ECOG Performance Status ≤ 2
- No prior chemotherapy or history of invasive cancer < 5years
- No metastases
Show all 19Show fewer
- Local treatment for the primary tumour (surgery and/or radiotherapy) achieved ≤ 30 days from randomization, chemotherapy to begin within 15 days.
- 6 - Contraception in women of child-bearing potential
- 7- Written informed consent
- 8- Patients with French Social Security in compliance with the French law relating to biomedical research.
- Non-Inclusion Criteria:
- Largest Tumor Diameter < 15 mm or Largest Tumor Diameter 15-18 mm without extrascleral extension and/or retinal detachment, in the absence of genomic alteration as defined per protocol or in the absence of Fine Needle Aspiration biopsy for genomic risk assessment.
- Contraindication to Fotemustine administration
- Hematological function : Hb < 10g/dL, absolute neutrophil count < 2,000/mm3, and platelets < 100,000/mm3
- Biochemistry results :Total bilirubin and AST/ALT > 1,5 UNL (Upper Normal Limit)
- Creatinine > 1,5 UNL (Upper Normal Limit)
- Pregnant and/or breastfeeding women.
- 8 - Previous history of cancer excepting in situ cervical carcinoma or cutaneous basal carcinoma.
- 7- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, viral or other hepatitis or cirrhosis, or psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France5 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Léon Bérard
Lyon, 69373
CHU Nice
Nice, 06003
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
About this study
Official title: Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between:
- Adjuvant chemotherapy with Fotemustin.
- Observation
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
Read the detailed description
High risk uveal melanoma is defined by :
- Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extra scleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/ OR
- Genomic high risk signature (aCGH +/-LOH): Monosomy 3 or partial deletion of 3p associated with any 8 gain.
Treatment schedule :
- Induction: Fotemustin 100 mg/m², D1-D8-D15, 1 hour IV infusion, 1 cycle
- Maintenance : restart on D50, Fotemustine : 100 mg/m², 1 hour IV infusion, D1 D21, 5 cycles.
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
Note :Based on the second interim analysis showing futility, and no chance to observe any significant statistical difference at the end of the study, the Independent Data Monitoring Committee recommended to stop randomization and amend the protocol to propose an interventional surveillance to high-risk patients as per protocol (April 2016).
- Conditions
- Uveal Melanoma
- Being tested
- Adjuvant chemotherapy by Fotemustin, Intensive surveillance
- Keywords
- Uveal melanoma, High risk of metastasis, Genomic high risk signature, Adjuvant chemotherapy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapy by FotemustinDrug
Also called Fotemustin
Fotemustin is given for 6 cycles :
- One Induction cycle: Fotemustin 100 mg/m², 1 hour IV infusion, D1D8D15, 5 week rest period, restart on D50.
- Five Maintenance cycles: Fotemustin 100 mg/m², 1 hour IV infusion, D1-D21.
Intensive surveillanceOther
Also called Surveillance
Intensive surveillance
- Total duration: 3 years.
- liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months.
| Study group | Role | What they receive |
|---|---|---|
| A : Chemotherapy | Experimental | Adjuvant chemotherapy by Fotemustin 100mg/m² Receives: Drug: Adjuvant chemotherapy by Fotemustin |
| B : Surveillance | Other | Intensive surveillance Receives: Other: Intensive surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-Free survival
Time between patient randomization and metastases occurrence or death
Measured: 3 years
Secondary outcomes (3)
Overall Survival
Time between patient randomization and death
Measured: 3 years
Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities
using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) V3
Measured: 3 years
Quality of life assessment
Using QLQ-C30 questionary.
Measured: Baseline, 6 months and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start23 Jun 2009
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Servier, UNICANCER
- Responsible party
- Sponsor
- Investigators
- Sophie PIPERNO-NEUMANN, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843386
- Sponsor's protocol ID
- IC 2008-03
- Acronym
- FOTEADJ
- Status last verified
- Aug 2022
- First submitted
- 21 Jul 2016
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma
- ClinicalTrials.gov ID
- NCT02843386
- Acronym / sponsor ID
- FOTEADJ / IC 2008-03
- Conditions
- Uveal Melanoma
- Keywords
- Uveal melanoma, High risk of metastasis, Genomic high risk signature, Adjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Servier, UNICANCER
- Study start
- 23 Jun 2009 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 25 Jul 2016 (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.
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between:
- Adjuvant chemotherapy with Fotemustin.
- Observation
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
Detailed description
High risk uveal melanoma is defined by :
- Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extra scleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/ OR
- Genomic high risk signature (aCGH +/-LOH): Monosomy 3 or partial deletion of 3p associated with any 8 gain.
Treatment schedule :
- Induction: Fotemustin 100 mg/m², D1-D8-D15, 1 hour IV infusion, 1 cycle
- Maintenance : restart on D50, Fotemustine : 100 mg/m², 1 hour IV infusion, D1 D21, 5 cycles.
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
Note :Based on the second interim analysis showing futility, and no chance to observe any significant statistical difference at the end of the study, the Independent Data Monitoring Committee recommended to stop randomization and amend the protocol to propose an interventional surveillance to high-risk patients as per protocol (April 2016).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A : Chemotherapy | Experimental | Drug: Adjuvant chemotherapy by FotemustinAdjuvant chemotherapy by Fotemustin 100mg/m² |
| B : Surveillance | Other | Other: Intensive surveillanceIntensive surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- High risk uveal melanoma, defined by :
- Age ≥ 18 years and ECOG Performance Status ≤ 2
- No prior chemotherapy or history of invasive cancer < 5years
- No metastases
- Local treatment for the primary tumour (surgery and/or radiotherapy) achieved ≤ 30 days from randomization, chemotherapy to begin within 15 days.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adjuvant chemotherapy by FotemustinAlso: FotemustinFotemustin is given for 6 cycles : * One Induction cycle: Fotemustin 100 mg/m², 1 hour IV infusion, D1D8D15, 5 week rest period, restart on D50. * Five Maintenance cycles: Fotemustin 100 mg/m², 1 hour IV infusion, D1-D21. | Drug | A : Chemotherapy |
| Intensive surveillanceAlso: SurveillanceIntensive surveillance * Total duration: 3 years. * liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months. | Other | B : Surveillance |
Primary outcome
Metastasis-Free survival
Time frame: 3 years
Time between patient randomization and metastases occurrence or death
3 secondary outcomes
Overall Survival
Time frame: 3 years
Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities
Time frame: 3 years
Quality of life assessment
Time frame: Baseline, 6 months and 3 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 31 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Sophie PIPERNO-NEUMANN, MD principal investigator
Institut Curie
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant chemotherapy by Fotemustin and Intensive surveillance in people with Uveal Melanoma, run by Institut Curie at 6 sites in 2 countries.
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 19 inclusion and 0 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Switzerland. 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?
Metastasis-Free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2022.