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Trial record 79 of 1294 for:    survival | Neuroendocrine Tumors

Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor (TERAVECT)

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ClinicalTrials.gov Identifier: NCT02465112
Recruitment Status : Terminated (Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).)
First Posted : June 8, 2015
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Digestive Neuroendocrine Tumors Metabolic Radiotherapy Resection Liver Metastases Drug: In111-Pentetréotide Other: simple monitoring without active therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2015
Actual Primary Completion Date : October 11, 2018
Actual Study Completion Date : October 11, 2018


Arm Intervention/treatment
Experimental: metabolic radiotherapy
In111-Pentetréotide at 12, 18 and 24 weeks after surgery,
Drug: In111-Pentetréotide
Active Comparator: No metabolic radiotherapy - simple monitoring
No metabolic radiotherapy - simple monitoring without theraoy
Other: simple monitoring without active therapy



Primary Outcome Measures :
  1. relapse-free survival (RFS) [ Time Frame: up to 3-year ]

Secondary Outcome Measures :
  1. Quality of life (EORTC QLQ-C30) [ Time Frame: up to 5-year ]
    At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up

  2. Tolerability [ Time Frame: up to 5-year after surgery ]
    Hematological and renal tolerability

  3. Overall survival (1) [ Time Frame: up to 3-year ]
  4. Overall survival (2) [ Time Frame: up to 5-year ]
  5. Identify predictive factors of RFS [ Time Frame: Up to 3-year ]
    Predictive factor : primary tumor location, proliferation index, bilobar or unilobar invasion, number of resected tumors and intratumoral SST2 density immunohistochemical detection.

  6. Impact of the therapy on 1-year RFS in treatment and control group [ Time Frame: Up to 1-year ]
  7. Impact of the therapy on 5-year RFS in treatment and control group [ Time Frame: Up to 5-year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465112


Locations
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France
Hôpital Haut Lévêque - CHU Bordeaux
Bordeaux, France, 33604
Hôpital Beaujon
Clichy, France, 92110
Hôpital R. Salengro
Lille, France, 59037
Hôpital Hôtel Dieu
Nantes, France
Hôptal Cochin
Paris, France, 75014
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Study Director: Rachida LEBTAHI, MD Hôpital Beaujon

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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02465112     History of Changes
Other Study ID Numbers: TERAVECT D13-2
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neuroendocrine Tumors
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Liver Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs