search
Back to results

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. (LEVEL)

Primary Purpose

Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
177Lu-edotreotide
Everolimus
Sponsored by
Grupo Espanol de Tumores Neuroendocrinos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent. Patients ≥ 18 years of age. Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning. Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index. In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging. Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery. Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments). Note: Somatostatin analogues for patients with functioning tumors are allowed. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1. An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria: Neutrophil count (ANC) ≥ 1,500/mm^3 Platelet count ≥ 75 × 10^9/L Hemoglobin ≥ 8 g/dL Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration. Subject agrees not to participate in another interventional study while on treatment in the present study. Exclusion Criteria: Patients who are not able to swallow tablets. Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible. Patients with brain mets unless stable on treatment for > 12 weeks and with no evidence of raised intracranial pressure or mass effect. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2). Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment. Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug. Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment). Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug. Patients who have had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS). Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.

Sites / Locations

  • Centre Hospitalier Universitaire (CHU) Bordeux
  • Lille University Hospital
  • Hôpital Edouard Herriot, Lyon
  • Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
  • Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
  • Centre Hospitalier Universitaire de Nantes
  • I. Gustave Roussy, Paris
  • Department of Digestive Oncology - IUCT Rangueil-Larrey, CHU de Toulouse, Toulouse, France
  • Azienda Ospedaliera Spedali Civili Brescia
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
  • AOU Policlinico G. Martino - Messina
  • Istituto Europeo di Oncologia - Milano
  • Istituto Nazionale Tumori IRCCS - Napoli
  • Unit of Nuclear Medicine, S. Maria Nuova Hospital-IRCCS of Reggio Emilia, Reggio Emilia, Italy
  • Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario Central de Asturias
  • ICO Institut Català d'Oncologia L'Hospitalet
  • Complexo Hospitalario Universitario de Santiago de Compostela
  • Hospital Universitari Vall d'Hebron
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Ramón y Cajal, Madrid
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Control arm

Arm Description

Treatment with 6 cycles of 7.5 ± 0.7 GBq 177Lu-edotreotide. The prescribed treatment administration is as follows: a 6 (±2) weeks interval between cycles 1 and 2 followed by all remaining cycles (3-6) given 8 (± 1) weeks after the previous cycle), where possible, or until disease progression, intolerable toxicity or death, whichever occurs first.

Everolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Progression-free survival (PFS) defined as the time from the date of randomization to the date of first documentation of disease progression according to RECIST 1.1 by investigator-assessment or death due to any cause, whichever occurs first. In the primary analysis, PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.

Secondary Outcome Measures

Objective response rate (ORR)
Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST v1.1. This will be considered as the percentage/proportion of randomized patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.
Disease control rate (DCR)
Percentage/proportion of randomized patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST v1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a DCR event.
Duration of response (DoR)
Time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Overall Survival (OS)
Defined as the time elapsed from randomization until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Patient reported quality of life
Assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) C30 (EORTC QLQ-C30), version 3 and lung cancer specific extension module LC-13. This are structural questionnaires self completed by the patient and which will give a numerical value to their own perception of quality of life. The scores obtained are standardized and a score between 0 (worst quality of life) and 100 (better quality of life).

Full Information

First Posted
March 6, 2023
Last Updated
June 23, 2023
Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Collaborators
ITM Oncologics GmbH, MFAR
search

1. Study Identification

Unique Protocol Identification Number
NCT05918302
Brief Title
Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Acronym
LEVEL
Official Title
Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Collaborators
ITM Oncologics GmbH, MFAR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.
Detailed Description
The LEVEL Trial is a randomized, prospective, international, open-label, phase III study comparing everolimus and 177Lu-edotreotide in advanced somatostatin receptor positive (SSTR+) lung and thymic well differentiated neuroendocrine tumors with high expression of somatostatin receptors confirmed by positron emission tomography somatostatin receptor imaging. In the investigator's opinion, patients recruited into the trial must be eligible to receive everolimus. Patients with both functional and nonfunctional lung and thymus neuroendocrine tumors (NETs) will be included in this trial. In total, 120 patients will be randomized in a 3:2 proportion to either experimental or control arms, respectively. Randomization will be stratified according to prior medical therapy (tumor treatment-naïve [patients who have not received any prior systemic anticancer therapy] versus non-treatment- naïve [patients who have received one or two prior line of systemic anticancer therapy, including somatostatin analogs (SSAs) as anti-tumor treatment]) and histological differentiation (typical versus atypical / well versus moderately differentiated). Stratification according to the functional status is not foreseen considering the poor predictive and prognostic relevance of this criteria on PRRT in the literature. Diagnosis of progression and tumor burden will be established based on radiological information from morphological imaging (magnetic resonance imaging [MRI] and/or computed tomography [CT]) according to RECIST v1.1. Tumors assessments will be scheduled every 12 ± 2 weeks from randomization (the first scan will be performed after Cycle 2 for the 177Lu-edotreotide until radiologically confirmed progression of the disease, initiation of new subsequent anticancer therapy, or death (whichever comes first). The scanning modality and protocol should be consistent with the baseline scan. Diagnosis of RECIST v1.1 progression will be made by the local investigator. The confirmatory scans should be performed preferably at the next scheduled imaging visit and no less than 4 weeks after the prior assessment of progression (PD) (in the absence of clinically significant deterioration). Additional MRI/CT scans may be performed at any other time if, in the investigator's clinical judgment, PD is suspected. For equivocal findings of progression, treatment may continue until the next scheduled assessment. In both arms, for a given patient, trial treatment dosing should be discontinued if there is evidence of RECIST v1.1 progression, in case of persistent toxicities or if the patient withdraws consent to continue with treatment. In all cases, if possible, all other protocol scheduled assessments should be continued until the end of the long-term follow-up period, unless the patient explicitly withdraws consent to all trial procedures and follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Treatment with 6 cycles of 7.5 ± 0.7 GBq 177Lu-edotreotide. The prescribed treatment administration is as follows: a 6 (±2) weeks interval between cycles 1 and 2 followed by all remaining cycles (3-6) given 8 (± 1) weeks after the previous cycle), where possible, or until disease progression, intolerable toxicity or death, whichever occurs first.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Everolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
177Lu-edotreotide
Intervention Description
6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
10 mg orally once daily (QD)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) defined as the time from the date of randomization to the date of first documentation of disease progression according to RECIST 1.1 by investigator-assessment or death due to any cause, whichever occurs first. In the primary analysis, PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.
Time Frame
Throughout the study period, approximately 3 years per patient
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST v1.1. This will be considered as the percentage/proportion of randomized patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.
Time Frame
Throughout the study period, approximately 3 years per patient
Title
Disease control rate (DCR)
Description
Percentage/proportion of randomized patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST v1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a DCR event.
Time Frame
Throughout the study period, approximately 3 years per patient
Title
Duration of response (DoR)
Description
Time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Time Frame
Throughout the study period, approximately 3 years per patient
Title
Overall Survival (OS)
Description
Defined as the time elapsed from randomization until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Time Frame
Throughout the study period, approximately 3 years per patient, at each visit. Long-term follow-up to be performed at least every 6 months.
Title
Patient reported quality of life
Description
Assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) C30 (EORTC QLQ-C30), version 3 and lung cancer specific extension module LC-13. This are structural questionnaires self completed by the patient and which will give a numerical value to their own perception of quality of life. The scores obtained are standardized and a score between 0 (worst quality of life) and 100 (better quality of life).
Time Frame
Throughout the study period, approximately 3 years per patient. Assessed every 12 weeks from randomization to progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent. Patients ≥ 18 years of age. Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning. Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index. In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging. Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery. Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments). Note: Somatostatin analogues for patients with functioning tumors are allowed. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1. An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria: Neutrophil count (ANC) ≥ 1,500/mm^3 Platelet count ≥ 75 × 10^9/L Hemoglobin ≥ 8 g/dL Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration. Subject agrees not to participate in another interventional study while on treatment in the present study. Exclusion Criteria: Patients who are not able to swallow tablets. Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible. Patients with brain mets unless stable on treatment for > 12 weeks and with no evidence of raised intracranial pressure or mass effect. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2). Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment. Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug. Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment). Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug. Patients who have had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS). Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Nepote
Phone
+34934344412
Email
investigacion@mfar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaume Capdevila, M.D. Ph.D.
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire (CHU) Bordeux
City
Bourdeaux
ZIP/Postal Code
33000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Hôpital Edouard Herriot, Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
I. Gustave Roussy, Paris
City
Paris
ZIP/Postal Code
94805
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Department of Digestive Oncology - IUCT Rangueil-Larrey, CHU de Toulouse, Toulouse, France
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Azienda Ospedaliera Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
AOU Policlinico G. Martino - Messina
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Istituto Europeo di Oncologia - Milano
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Istituto Nazionale Tumori IRCCS - Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Unit of Nuclear Medicine, S. Maria Nuova Hospital-IRCCS of Reggio Emilia, Reggio Emilia, Italy
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
ICO Institut Català d'Oncologia L'Hospitalet
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Complexo Hospitalario Universitario de Santiago de Compostela
City
Santiago De Compostela
State/Province
Galicia
ZIP/Postal Code
28042
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the Sponsor, M.D.
Facility Name
Hospital Universitario Ramón y Cajal, Madrid
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
a responsible person Designated by the sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Responsible person Designated by the Sponsor
Phone
+34934344412
Email
investigacion@mfar.net
First Name & Middle Initial & Last Name & Degree
A Principal Investigator Designated by the sponsor, M.D.
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Analyzed compiled results will be publicly available to support the conclusion from the study. Individual data will be available upon reasonable request.

Learn more about this trial

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

We'll reach out to this number within 24 hrs