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Trial record 2 of 748 for:    Recruiting, Not yet recruiting, Available Studies | Neuroendocrine tumors

Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors (LUNET)

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ClinicalTrials.gov Identifier: NCT02489604
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • Disease control rate (DCR) [ Time Frame: up to 7 years ]
    the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population randomly assigned to two different scheme of therapy
  • Acute toxicity evaluated according to version 4.0 CTCAE [ Time Frame: The evaluation of the acute toxicity starts from the 1st treatment until 30 days after the last treatment cycle, up to 60 wks for each patient ]
    The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02489604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • Progression free survival [ Time Frame: up to 7 years ]
    the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
  • Overall survival [ Time Frame: up to 7 years ]
    Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
  • Late toxicity evaluated according to version 4.0 CTCAE [ Time Frame: up to 7 years ]
    late toxicity will be evaluated during the whole study period according to version 4.0 CTCAE
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors
Official Title  ICMJE Peptide Receptor Radionuclide Therapy (PRRT) With Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized Study
Brief Summary This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).
Detailed Description

This is a randomized phase II non-comparative study. Patients with GEP-NET G1-G2 with progressive disease, somatostatin receptor (SSR) positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq). The two levels of dosages are:

  1. Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi)
  2. Total activity of 18.5 GBq 100 mCi for 5 cycles at 6 ± 2 weeks (500 mCi) The randomized study design allows for two active treatments to be evaluated in a comparable patient population. The estimates of primary objectives can be evaluated for each regimen separately by a Bryant and Day design. While the sample size is not powered for statistical test of a specific hypothesis for comparison between groups, this study design allows the unbiased collection of activity and safety in these two regimens in the same population, which will be useful for planning future studies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: 177Lu-DOTATATE 25.9 GBq activity
    177Lu-DOTATATE will be administered in a 30 minutes infusion. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)
    Other Name: 177Lu-DOTATATE
  • Drug: 177Lu-DOTATATE 18.5 GBq activity
    177Lu-DOTATATE will be administered in a 30 minutes infusion Total activity of 18.5 GBq 100 mCi for 5 cycles , every 6 ± 2 weeks (500 mCi)
    Other Name: 177Lu-DOTATATE
Study Arms  ICMJE
  • Experimental: 177Lu-DOTATATE 25.9 GBq activity
    177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)
    Intervention: Drug: 177Lu-DOTATATE 25.9 GBq activity
  • Experimental: 177Lu-DOTATATE 18.5 GBq activity
    177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi)
    Intervention: Drug: 177Lu-DOTATATE 18.5 GBq activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67 index <= 20%.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.criteria)
  • Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria
  • Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
  • FDG PET negative (SUV less than 2.5)
  • Concomitant somatostatin analogs assumption is allowed
  • Life expectancy greater than 6 months.
  • ECOG performance status <2
  • Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL) , Alanine transaminase (ALT) <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL.
  • If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • Ki 67 index > 20 %
  • FDG PET positive at least in one documented lesion with a SUV more than 2.5
  • Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).
  • Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.
  • All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oriana Nanni, PhD +390543739266 oriana.nanni@irst.emr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489604
Other Study ID Numbers  ICMJE IRST100.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor  ICMJE Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maddalena Sansovini, MD IRST IRCCS
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP