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Ewing Sarcoma Family of TumorsPhase 2CombinaiR3NCT03011528

First-line Treatment of Ewing Tumours With Primary Extrapulmonary Dissemination in Patients From 2 to 50 Years (CombinaiR3)

A Phase 2 study testing VDC-IE x2, VDC-IE and TEMIRI in people with Ewing Sarcoma Family of Tumors, run by Institut Curie at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the second decade of life. They start most often from bone, and are characterized by a specific translocation involving the so-called EWS gene. Read more about this study

Who is it for?
Ages 2 to 50 years
Conditions the study is for
Ewing Sarcoma Family of Tumors
What is being tested?
VDC-IE x2, VDC-IE and TEMIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
17 sitesFrance
Study dates
Dec 2016to Nov 2023
Phase
Phase 2
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 2 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • - Ewing tumour histologically or cytologically confirmed, harboring a specific transcript, and with extrapulmonary metastases (including nodal extension) - histology and FISH results must be consistent, specific transcript can be obtained after inclusions.
  • - Ewing tumour not previously treated.
  • - Age between 2 and 50 years.
  • - Measurable disease by cross sectional imaging (RECIST 1.1) or evaluable disease with functional metabolic, positron emission tomography scanner (PET SCAN) or other methods (e.g., cytology/histology).
  • - General status compatible with the study treatments (LANSKY score ≥ 50%, or Karnofsky ≥ 50%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2).
  • - Adequate bone marrow function (not applicable in case of bone marrow disease).
Show all 22Show fewer
  • Platelets ≥ 100 x 109 /L
  • Absolute Neutrophil Count (ANC) ≥ 1 x 109 /L
  • Hemoglobin ≥ 8g /dL.
  • - Adequate liver function :
  • Aspartate Aminotransferase (AST) and Alanine Transferase (ALT) ≤ 5 x Upper Limit Normal (ULN)
  • Total Bilirubin ≤ 2 Upper Limit Normal (ULN). If total bilirubin > 2xULN, Bilirubin Conjugated Fraction (BCF) ≤ 2 x ULN
  • - No absolute contra-indication of Busulfan-Melphalan if radiotherapy of the primary tumour is necessary with specific attention to patient with primary spinal tumor.
  • - Adequate cardiac and renal functions:
  • Creatinine < 1.5 of normal for age or clearance > 60 ml/min/1.73 m²;
  • Left Ventricular Ejection Fraction (LVEF) > 50% and/or shortening fraction > 28%.
  • - No underlying disease contra-indicating the study treatments.
  • - Patient likely compliant with the recommended study medical monitoring during and after treatments.
  • - Patients of childbearing potential must agree to use adequate contraception for the duration of study treatments and up to 12 months for women and 6 months for men following completion of therapy.
  • - Females of childbearing potential must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test within 10 days prior study inclusion, and/or urine pregnancy test within 48 hours before the first administration of the study treatment.
  • - Patients covered by a health insurance system.
  • - Patient, or patient's legal representative, informed and having signed the informed consent.

Who cannot join

  • - Age below 2 or greater than 50 years.
  • - Ewing tumour localized, or solely with pleural and/or lung metastases.
  • - Concomitant disease, particularly infectious disease, likely to interfere with patient's treatment.
  • - History of cancer, according to investigator's judgment.
  • - Life expectancy < 2 months.
  • - Patient already included in another clinical trial with an investigational drug.
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  • - Pregnant or breastfeeding patient.
  • - Person deprived of liberty or under guardianship.
  • - Patient likely unable to comply with the study medical monitoring for geographical, social or psychological reasons.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Bordeaux Chu

    Bordeaux, 33076

  • CHU Grenoble Alpes

    Grenoble, 38043

  • Chr Felix Guyon

    La Réunion, Saint Denis, 97400

  • LILLE Centre Oscar Lambret

    Lille, 59000

  • LYON Centre Léon Bérard

    Lyon, 69000

  • Marseille Chu

    Marseille, 13000

  • CHRU Montpellier - Hôpital A. de Villeneuve

    Montpellier, 34295

  • Nantes Chu

    Nantes, 44000

  • PARIS Institut Curie

    Paris, 75005

  • PARIS Trousseau

    Paris, 75012

  • CHU Hôpital Sud

    Rennes, 35056

  • Strasbourg Chu

    Strasbourg, 67098

  • Toulouse Chu

    Toulouse, 31059

  • TOULOUSE Institut Claudius Regaud

    Toulouse, 31059

  • Nancy Chu

    Vandœuvre-lès-Nancy, 54511

  • NANCY Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • VILLEJUIF Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: CombinaiR3 - First-line Treatment of Ewing Tumours With Primary Extrapulmonary Dissemination in Patients From 2 to 50 Years

Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the second decade of life. They start most often from bone, and are characterized by a specific translocation involving the so-called EWS gene. In one patient out of three, the staging procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and bone marrow.

ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local treatment, and consolidation chemotherapy.

Read more

The primary metastatic dissemination is the most important prognostic factor, as the survival rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with primary metastatic disease.

Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the prognosis of these patients. While the long-term survival of patients with isolated pleural pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with bone marrow involvement.

In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients), the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation with high dose chemotherapy to a higher rate of patients. The high-dose Busulfan Melphalan chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with autologous peripheral blood stem cell (PBSC) support.

Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was 27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after diagnosis, and a median survival time of 1.6 years.

Read the detailed description

Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the second decade of life. They start most often from bone, and are characterized by a specific translocation involving the so-called EWS gene. The gene rearrangement results in the production of a transcription factor, in the majority EWS-FLI1 transcription.

In one patient out of three, the staging procedures detect metastatic tumours at the diagnosis; metastases involve most commonly lungs, bones, and bone marrow.

Therefore, in addition to local imaging, the initial extension assessment of any Ewing tumour includes at least a chest CT scan, and a bone marrow extensive evaluation, comprising bone marrow punctures into several different sectors, bone marrow biopsies, and a bone imaging evaluation. The FDG-PET scan is more sensible than bone scan and conventional imaging as MRI in detection of bone metastases. It is more and more widely used in the bone metastasis search in Ewing tumours and seems useful to complement the search of extra-osseous metastases (outside the lungs), including that of bone marrow metastases. The full-body MRI is still under evaluation for the disease extension evaluation.

ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local treatment, and consolidation chemotherapy. The local treatment may combine surgery and / or radiotherapy, according to the tumour site and size, and to the tumour response. ESFT chemotherapy is based on alkylating agents (ifosfamide and / or cyclophosphamide), etoposide, anthracyclines, vincristine, and actinomycin.

The primary metastatic dissemination is the most important prognostic factor, as the survival rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with primary metastatic disease. Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the prognosis of these patients. While the long-term survival of patients with isolated pleural pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with bone marrow involvement.

In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing tumours, localized or metastatic and below 50 years of age. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients), the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation with high dose chemotherapy to a higher rate of patients. The high-dose BuMel chemotherapy was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with autologous peripheral blood stem cell (PBSC) support.

The study enrolled 281 patients with primary dissemination and skeletal metastases, with or without bone marrow involvement and with or without additional pulmonary metastases or metastases to other sites. In contrast to the distribution in the entire group of patients with Ewing tumours, the primary site in this subgroup was extremity in only 31% patients, pelvis/abdomen in 45%, and axial/other in 24% patients. The overall survival at 3 years was 28% (SD 4%) in the group with primary tumour in the abdomen or pelvis, versus 39% (SD 6%) for each of the two other groups. Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was 27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after diagnosis, and a median survival time of 1.6 years.

Being tested
VDC-IE x2, VDC-IE, TEMIRI, Consolidation BuMel, Maintenance
Medical subject headings
Neuroectodermal Tumors, Primitive, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VDC-IE x2Drug

    Also called Intensified Induction VDC-IE x2

    Week 1, 5, 9 and week 13:

    • Vincristine, IV, D1, 1.5mg/m²
    • Doxorubicine, IV, D1-D2, 37.5mg/m²
    • Cyclophosphamide, IV, D1, 1.2g/m²

    Week 3, 7, 11 and week 15:

    • Ifosfamide, IV, D15 to D19, 1.8g/m²/d
    • Etoposide, IV, D15 to D19, 100mg/m²/d

  • VDC-IEDrug

    Also called Intensified Induction VDC-IE

    Week 1 and week 5:

    • Vincristine, IV, D1, 1.5mg/m²
    • Doxorubicine, IV, D1-D2, 37.5mg/m²
    • Cyclophosphamide, IV, D1, 1.2g/m²

    Week 3, and week 7:

    • Ifosfamide, IV, D15 to D19, 1.8g/m²/d
    • Etoposide, IV, D15 to D19, 100mg/m²/d

  • TEMIRIDrug

    Also called Intensified Induction TEMIRI

    Week 9, 12, 15 and week 18:

    • Temozolomide, PO, D1 to D5, 150mg/m²/d
    • Irinotecan, IV, D1 to D5, 50mg/m²/d

  • Consolidation BuMelDrug

    Also called High dose Consolidation chemotherapy

    After induction phase and local treatment (surgery and/or radiotherapy) and before PBSC:

    • Busulfan, IV, D-5 to D-2, dosa according to the weight
    • Melphalan, IV, D-1, 140 mg/m²

    Peripheral Blood Stem Cell infusion:

    • PBSC infusion, D0, at least 3.10^6 CD34/kg

  • MaintenanceDrug

    Also called 2 years maintenance

    • 1st year : VC
    • Vinblastine, IV, 3mg/m², once a week (except during radiotherapy: 1mg/m², 3 times a week)
    • Cyclophosphamide, PO, 25mg/m² continuously

  • Local treatment by surgeryProcedure or surgery

    Also called Surgery of primary tumour/metastatic sites

    Surgical excision of whole site of the primary tumour and metastatic sites (outside pulmonary sites) can take place before or after the high dose consolidation chemotherapy. Radiotherapy can be added

  • Local treatment by radiotherapyRadiation

    Also called Radiotherapy of primary tumour/metastatic sites

    Radiotherapy of whole site of the primary tumour and metastatic sites (outside pulmonary sites) can take place before or after the high dose consolidation chemotherapy

Study groups in NCT03011528
Study groupRoleWhat they receive
VDC - IE x2 & SurgeryOtherPatients in Arm A receive * VDC-IE x2: Intensified induction phase: * 4 cycles of VDC (Vincristine Doxorubicine Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association if "good response" after the 4th treatment, followed by: * 4 cycles of VDC (Vincristine-Doxorubicine-Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association * Consolidation BuMel High dose chemotherapy (Busulfan Melphalan) followed by Peripheral Blood Stem Cell Infusion * Local treatment by surgery of primary tumour/metastatic sites (outside pulmonary sites): indicated before of after consolidation phase (BuMel) among multidisciplinary decision. Radiotherapy can be added * Maintenance phase * 1st year : VC (Vincristine Cyclophosphamide) association * 2nd year : Cyclophosphamide po 25 mg/m²
Receives: Drug: VDC-IE x2; Drug: Consolidation BuMel; Drug: Maintenance; Procedure: Local treatment by surgery; Radiation: Local treatment by radiotherapy
VDC - IE & TEMIRI & SurgeryOtherPatients in Arm B receive * VDC-IE \& TEMIRI: Intensified induction phase: * 4 cycles of VDC (Vincristine-Doxorubicine-Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association if "poor response" after the 4th treatment, followed by: * 4 cycles of TEMIRI (Temozolomide-Irinotecan) association * Local treatment by surgery of primary tumour/metastatic sites (outside pulmonary sites): indicated before of after consolidation phase (BuMel) among multidisciplinary decision. Radiotherapy can be added * Consolidation BuMel High dose chemotherapy (Busulfan-Melphalan) followed by Peripheral Blood Stem Cell Infusion * Maintenance phase * 1st year : VC (Vincristine Cyclophosphamide) association * 2nd year : Cyclophosphamide po 25 mg/m²
Receives: Drug: VDC-IE; Drug: TEMIRI; Drug: Consolidation BuMel; Drug: Maintenance; Procedure: Local treatment by surgery; Radiation: Local treatment by radiotherapy
VDC - IE x2 & RadiotherapyOtherPatients in Arm C receive * VDC-IE x2: Intensified induction phase: * 4 cycles of VDC (Vincristine-Doxorubicine-Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association if "good response" after the 4th treatment, followed by: * 4 cycles of VDC (Vincristine-Doxorubicine-Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association * Consolidation BuMel High dose chemotherapy (Busulfan-Melphalan) followed by Peripheral Blood Stem Cell Infusion * Local treatment by radiotherapy of primary tumour/metastatic sites (outside pulmonary sites): indicated before of after consolidation phase (BuMel) among multidisciplinary decision. * Consolidation BuMel High dose chemotherapy (Busulfan-Melphalan) followed by Peripheral Blood Stem Cell Infusion * Maintenance phase * 1st year : VC (Vincristine Cyclophosphamide) association * 2nd year : Cyclophosphamide po 25 mg/m²
Receives: Drug: VDC-IE x2; Drug: Consolidation BuMel; Drug: Maintenance; Radiation: Local treatment by radiotherapy
VDC - IE & TEMIRI & RadiotherapyOtherPatients in Arm D receive * VDC-IE \& TEMIRI: Intensified induction phase: * 4 cycles of VDC (Vincristine-Doxorubicine-Cyclophosphamide) association alternative with 4 cycles of IE (Ifosfamide-Etoposide) association if "poor response" after the 4th treatment, followed by: * 4 cycles of TEMIRI (Temozolomide-Irinotecan) association * Local treatment by radiotherapy of primary tumour/metastatic sites (outside pulmonary sites): indicated before of after consolidation phase (BuMel) among multidisciplinary decision. * Consolidation BuMel High dose chemotherapy (Busulfan-Melphalan) followed by Peripheral Blood Stem Cell Infusion * Maintenance phase * 1st year : VC (Vincristine Cyclophosphamide) association * 2nd year : Cyclophosphamide po 25 mg/m²
Receives: Drug: VDC-IE; Drug: TEMIRI; Drug: Consolidation BuMel; Drug: Maintenance; Radiation: Local treatment by radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-tumour effect of the treatment strategy assessed by the number of patients event-free survival (EFS) at 18 months

    EFS is defined as the time from inclusion date to the first documentation of progression, distant disease, second cancer or death (or last news for patients free of event). The event free survival is estimated by Kaplan-Meier method.

    Measured: 18 months after inclusion of the last patient

Secondary outcomes (12)

  1. Anti-tumour effect of the dose-intensified induction chemotherapy assessed by the response rate of patients

    Number of patients with complete response (CR) / partial response (PR) eligible for consolidation phase

    Measured: week 19-20 = Response Evaluation 2 (RE2)

  2. Anti-tumour effect of the dose-intensified induction chemotherapy assessed by the number of patients eligible for consolidation phase

    Number of patients eligible for consolidation phase have good response after induction phase :

    • complete remission on primary tumour and on metastatic sites or
    • very good disease response defined by:
    • complete or partial response according to RECIST 1.1 criteria on primary lesion
    • complete or very good partial response (> 90 %) in case of RECIST 1.1 criteria on metastatic sites AND
    • complete metabolic response in case of metastatic visceral and/or bone/bone marrow lesions, or very good partial response according to investigator's judgment AND
    • in case of bone marrow involvement, bone marrow free of disease on at least one biopsy and two punctures at different sites at RE1 (evaluation after 4 cycles VDC-IE), RE2 (evaluation after 2x4 cycles VDC-IE or 4 cycles VDC-IE+4 cycles TEMIRI), or at the latest RE3 evaluation (evaluation after local treatment).

    Measured: week 19-20 = RE2

  3. Overall survival (OS) is assessed by the number of patients still alive at the end of the three years of treatment

    The overall survival (OS) is estimated by Kaplan-Meier method.

    Measured: 3 years = Response Evaluation End-Of-Treatment (EOT RE)

  4. 3-years event-free survival (EFS) is assessed by the number of patients without any event at the end of treatment phase

    EFS is defined as the time from inclusion date to the first documentation of progression, distant disease, second cancer or death (or last news for patients free of event). The event free survival is estimated by Kaplan-Meier method.

    Measured: 3 years = EOT RE

  5. Number of patients with treatment-related adverse events as assessed by CTCAE v4.03

    Number of patients with treatment-related adverse events using the NCI CTCAE version 4.03 to graduate the severity of adverse events

    Measured: week 19-20 = RE2 ; week 27-28 = Response Evaluation 3 (RE3); 3 years = EOT RE

  6. Number of patients with treatment-related toxicities on laboratory data as assessed by CTCAE v4.03 of the different phases of treatment

    Number of patients with treatment-related toxicities on laboratory data using the NCI CTCAE version 4.03 to graduate the severity of toxicities

    Measured: week 19-20 = RE2 ; week 27-28 = RE3; 3 years = EOT RE

  7. 18F-FDG PET evaluation efficacy assessed by primary tumour uptake

    Efficacy assessed by primary tumour uptake (Standardized Uptake Value max at 18F-FDG PET)

    Measured: study inclusion, after week 8 (RE1), after week18-19 (if VDC-IE) or week19-20 (if TEMIRI)=RE2, after local treatment ≤week30 (RE3), from week31 (=RE4), 3 years = EOT RE

  8. 18F-FDG PET evaluation efficacy assessed by metabolic tumour volume (MTV)

    Efficacy assessed by metabolic tumour volume (MTV at 18F-FDG PET)

    Measured: study inclusion, after week 8 (RE1), after week18-19 (if VDC-IE) or week19-20 (if TEMIRI)=RE2, after local treatment ≤week30 (RE3), from week31 (=RE4), 3 years = EOT RE

  9. Percentage of circulating tumour cells in blood and bone marrow to correlate with patient outcome (EFS). Ancillary study

    sample collected : primary tumour and metastatic site (if possible)

    Measured: study inclusion, and/or during Procedure=surgery (if done) either after week 19-20=RE2 or after PBSC infusion=RE4

  10. Percentage of circulating tumour cells in blood and bone marrow to correlate with patient outcome (EFS). Ancillary study

    sample collected : blood

    Measured: study inclusion, at each evaluation time (RE1=week8 to Response Evaluation before maintenance therapy (RE5=<week38)), every 3 months during 2 years maintenance therapy, at End of Treatment

  11. Percentage of circulating tumour cells in blood and bone marrow to correlate with patient outcome (EFS). Ancillary study

    sample collected : bone marrow

    Measured: at diagnosis (before treatment), at 1st evaluation time (RE1=wk8 if bone marrow involvement at diagnosis), at RE2=week19-20 (or RE3=<week30), after PBSC infusion=RE4 or RE5=< week38 (if bone marrow involvement at diagnosis), at End of Treatment

  12. Comparison of transcriptomic profiles between those of primary disease and those of bone marrow metastases to determine if they are the same or not. Ancillary study

    Investigation whether the cells from metastatic material harbour a unique transcriptomic signature compared to primary tumour cells : quantification of EWS-ETS transcript and EWS-ETS gene using Polymerase Chain Reaction (PCR) methods to determine the genomic EWS-ETS translocation loci

    Measured: study inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionAug 2022
  4. Study completionNov 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011528
Sponsor's protocol ID
IC 2015-13
Acronym
CombinaiR3
Status last verified
Nov 2025
First submitted
6 Dec 2016
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Publications

  • Laurence V, Jehanno N, Dureau S, Mous L, Claude L, Ballet S, Pierron G, Gaspar N, Brahmi M, Valentin T, Revon-Riviere G, Lervat C, Probert J, Entz-Werle N, Mansuy L, Plantaz D, Rios M, Saumet L, Verite C, Castex MP, Thebaud E, Cassou-Mounat T, Plissonnier AS, Dieppedale J, Delattre O, Legrier ME, Marec-Berard P, Gouin F, Berlanga P, Cordero C, Surdez D, Corradini N. Interest of a sequential multimodal approach for the treatment of newly diagnosed patients with multimetastatic Ewing sarcoma: results of the French prospective CombinaiR3 phase II trial. Br J Cancer. 2026 Jan;134(2):279-288. doi: 10.1038/s41416-025-03263-3. Epub 2025 Nov 17.

    PubMed 41249450

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VDC-IE x2, VDC-IE and TEMIRI in people with Ewing Sarcoma Family of Tumors, run by Institut Curie at 17 sites 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 22 inclusion and 9 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Anti-tumour effect of the treatment strategy assessed by the number of patients event-free survival (EFS) at 18 months (time frame: 18 months after inclusion of the last patient). 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 NCT03011528, which also lists 1 linked publication.

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 21 Nov 2025.

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