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Trial record 7 of 10 for:    somatostatin analogues AND 177Lu- | Neuroendocrine Tumors

Optimizing the Interval Between Cycles of PRRT With 177lu-dotatate in sstr2 Positive Tumors (LUTHREE)

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ClinicalTrials.gov Identifier: NCT03454763
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 6, 2018
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE May 26, 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • PFS [ Time Frame: up to 5 years ]
    Progression free survival is defined as the time from the randomization date to the date of first observation of documented disease progression or death due to any cause
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 30 days after last treatment cycle ]
    The evaluation of Treatment-Emergent Adverse Events, defined as any G3/G4 toxicity from 1st treatment cycle until 30 days after the last treatment cycle will be based on version 4.0 CTC-AE
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • DCR [ Time Frame: up to 5 years ]
    Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease for at least 12 weeks from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST)
  • OS [ Time Frame: up to 5 years ]
    Overall Survival (OS) is defined as the time from treatment start to the time of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
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 Optimizing the Interval Between Cycles of PRRT With 177lu-dotatate in sstr2 Positive Tumors
Official Title  ICMJE Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate
Brief Summary Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate
Detailed Description

The main objective of this randomized phase II comparative study is to evaluate the Progression Free survival (PFS) and the safety as co-primary objective of two different schedule of administrations of 177lu-dotatate: intensive (every 5 weeks) vs no intensive (every 8-10 weeks) The secondary objectives are DCR, the late toxicity, OS and dosimetry. Patients with any tumor histotype documented as sst2-positive in pre-study period will be enrolled in the study.

The study will include a total of 618 planned patients. They will be randomly assigned to receive 5 cycles of PRRT at intervals of 5 or 8-10 weeks between cycles.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: PRRT every 5 weeks
    PRRT (radiolabelled somatostatin analogues) every 5 weeks for 5 cycles
  • Drug: PRRT every 8-10 weeks
    PRRT (radiolabelled somatostatin analogues) every 8-10 weeks for 5 cycles
Study Arms  ICMJE
  • Experimental: Arm A, Intensive
    Arm A, Intensive every 5 weeks
    Intervention: Drug: PRRT every 5 weeks
  • Experimental: Arm B, Non Intensive
    Arm B, Non Intensive every 8-10 weeks
    Intervention: Drug: PRRT every 8-10 weeks
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: March 5, 2018)
618
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >18 years.
  2. Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive (, that may benefit from receptor radionuclide therapy and for which there aren't any other effective treatments.
  3. Measurable disease according to RECIST 1.1.criteria also patients without measurable but with evaluable disease disease can be enrolled.
  4. Any disease stage is allowed. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan (the tumour uptake will be evaluated with a 3-grade scale, where 1 = liver uptake, 2 > liver uptake and < kidney uptake and 3 > kidney uptake: only tumour uptakes grade 2 and 3 will be considered for therapy) and/or Positron Emission Tomography (PET)/CT 68Ga-peptide images demonstrate a significant uptake in the tumour.
  5. Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed
  6. Patients with or without concurrent therapy with somatostatin analogs
  7. Life expectancy of greater than 6 months.
  8. Eastern Cooperative Oncology Group (ECOG) performance status <2
  9. 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 aminotransferase ( ALT) and Aspartate aminotransferase (AST) <2.5 X UNL (< 5 X UNL in presence of liver metastases, creatinine < 2 mg/dL.
  10. If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) are mandatory.
  11. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  1. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.
  2. Patients treated with previous radio-metabolic therapy with an adsorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry (13).
  3. 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)
  4. ECOG performance status >2
  5. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  6. 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.
  7. Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e bone scan or CT or MRI)
  8. Pregnant or breastfeeding women are excluded from the present study.
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 +390543739266 oriana.nanni@irst.emr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454763
Other Study ID Numbers  ICMJE IRST100.26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Study Chair: Giovanni Paganelli, MD IRST IRCCS
Principal Investigator: Stefano Severi, MD IRST IRCCS
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date March 2018

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