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A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT03049189
Title field or adapter rule
{'original_value': 'A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:22.981848+00:00
Published At
2026-04-06T00:00:00+00:00
Record Updated At
2026-10-20
Results Posted At
2026-04-06
Source Retrieved At
2026-10-31T22:17:52.415050+00:00
Timestamp Basis
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Neuroendocrine Tumors"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-20", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT03049189"
protocolSection.identificationModule.officialTitle
"A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)"
protocolSection.statusModule.overallStatus
"ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases
["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct
{"date": "2026-04-06", "type": "ACTUAL"}

Study condition terms

  • Neuroendocrine Tumors (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['177Lu-edotreotide PRRT'], 'description': 'PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.', 'name': '177Lu-edotreotide PRRT', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Everolimus'], 'description': 'Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.', 'name': 'Everolimus', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['177Lu-edotreotide PRRT'], 'description': 'The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT', 'name': 'Amino-Acid Solution', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

  • 177Lu-edotreotide PRRT (protocolSection.armsInterventionsModule.interventions[].name)
  • Everolimus (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.