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Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor (TERAVECT)
A Randomized Phase III of Adjuvant Targeted Radionuclide Therapy With In111-Pentetreotide in Patients With Digestive Neuroendocrine Tumors After Complete Surgical Resection of Liver Metastases.
TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy.
In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Bordeaux, Frankrijk, 33604
- Hopital Haut Lévèque - CHU Bordeaux
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Clichy, Frankrijk, 92110
- Hopital Beaujon
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Lille, Frankrijk, 59037
- Hopital R. Salengro
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Nantes, Frankrijk
- Hôpital Hotel Dieu
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Paris, Frankrijk, 75014
- Hôptal Cochin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Signed and dated informed consent,
- Age ≥ 18 years,
- Patients with well differenciated digestive neuroendocrine tumors and liver metastases, for whom a complete surgical resection of liver metastases and of the primary tumor was performed, in 1 or 2 times,
- Immunohistochemical confirmation of neuroendocrine tumors with WHO 2010 grading specification and Ki67 determined of the surgical specimen,
- ECOG Performance Status (PS) 0-1,
- Adequate hematological status: Platelets >100000/mm3, Hemoglobin >10g/dL,
- Adequate Clearance Creatinine >60 mL/min,
- Adequate liver function: Total Serum Bilirubin <1.5x upper limit of normal (ULN), transaminases <3 x ULN,
- Grade of In111-Pentetreotide uptake ≥ 2 (scored according to the Krenning et al scale.: more intense than physiological liver uptake),
- Treatment started within 14 weeks after surgical resection,
- Men and women are required to use adequate birth control measures during the course of the study and for a period of 12 months after the last administration of study drug. Female patients with childbearing potential must have a negative serum pregnant test (β-HCG) within 7 days before starting study treatment,
- Life expectancy >6 months
- Registration with the National Health Care System (CMU included for France)
Exclusion Criteria:
- History of previous or second cancer or progressive cancer occurring within 5 years prior to inclusion, except for basal cell or squamous cell carcinoma,
- Patients with known sensibility or hypersensibility to In111- Pentetreotide or any component of the treatment drug,
- Pregnant or breast-feeding women without adequate birth control measures,
- Patient with known medical history of psychological or psychiatric disorders that may affect patient participation in study due to lack of cooperation or loss of autonomy preventing hospitalization and initiation of study treatment (in good radiation protection conditions),
- Treatment with any investigational drug within 28 days prior to study entry,
- Patient protected by law (tutelage or guardianship).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: metabolic radiotherapy
In111-Pentetréotide at 12, 18 and 24 weeks after surgery,
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Actieve vergelijker: No metabolic radiotherapy - simple monitoring
No metabolic radiotherapy - simple monitoring without theraoy
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
relapse-free survival (RFS)
Tijdsspanne: up to 3-year
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up to 3-year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Quality of life (EORTC QLQ-C30)
Tijdsspanne: up to 5-year
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At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
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up to 5-year
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Tolerability
Tijdsspanne: up to 5-year after surgery
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Hematological and renal tolerability
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up to 5-year after surgery
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Overall survival (1)
Tijdsspanne: up to 3-year
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up to 3-year
|
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Overall survival (2)
Tijdsspanne: up to 5-year
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up to 5-year
|
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Identify predictive factors of RFS
Tijdsspanne: Up to 3-year
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Predictive factor : primary tumor location, proliferation index, bilobar or unilobar invasion, number of resected tumors and intratumoral SST2 density immunohistochemical detection.
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Up to 3-year
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Impact of the therapy on 1-year RFS in treatment and control group
Tijdsspanne: Up to 1-year
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Up to 1-year
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Impact of the therapy on 5-year RFS in treatment and control group
Tijdsspanne: Up to 5-year
|
Up to 5-year
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Rachida LEBTAHI, MD, Hopital Beaujon
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata van het spijsverteringsstelsel
- Lever Ziekten
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neoplastische processen
- Neoplasma metastase
- Lever neoplasmata
- Neuro-endocriene tumoren
Andere studie-ID-nummers
- TERAVECT D13-2
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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