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

Primary Purpose

Neuroendocrine Tumors

Status

Active

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

177Lu-DOTATATE 25.9 GBq activity

177Lu-DOTATATE 18.5 GBq activity

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring neuroendocrine tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Irst Irccs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

177Lu-DOTATATE 25.9 GBq activity

177Lu-DOTATATE 18.5 GBq activity

Arm Description

177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)

177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi)

Outcomes

Primary Outcome Measures

Disease control rate (DCR)

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

The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE

Secondary Outcome Measures

Progression free survival

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

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

late toxicity will be evaluated during the whole study period according to version 4.0 CTCAE

Full Information

NCT ID

NCT02489604

First Posted

June 16, 2015

Last Updated

September 13, 2023

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

1. Study Identification

Unique Protocol Identification Number

NCT02489604

Brief Title

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

Acronym

LUNET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Data Monitoring Committee

5. Study Description

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: Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors

Keywords

neuroendocrine tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

177Lu-DOTATATE 25.9 GBq activity

Arm Type

Experimental

Arm Description

177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)

Arm Title

177Lu-DOTATATE 18.5 GBq activity

Arm Type

Experimental

Arm Description

177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi)

Intervention Type

Drug

Intervention Name(s)

177Lu-DOTATATE 25.9 GBq activity

Other Intervention Name(s)

177Lu-DOTATATE

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

177Lu-DOTATATE 18.5 GBq activity

Other Intervention Name(s)

177Lu-DOTATATE

Intervention Description

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)

Primary Outcome Measure Information:

Title

Disease control rate (DCR)

Description

Time Frame

up to 7 years

Title

Acute toxicity evaluated according to version 4.0 CTCAE

Description

The co-primary objective is the 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

Secondary Outcome Measure Information:

Title

Progression free survival

Description

Time Frame

up to 7 years

Title

Overall survival

Description

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.

Time Frame

up to 7 years

Title

Late toxicity evaluated according to version 4.0 CTCAE

Description

late toxicity will be evaluated during the whole study period according to version 4.0 CTCAE

Time Frame

up to 7 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maddalena Sansovini, MD

Organizational Affiliation

IRST IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Irst Irccs

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

12. IPD Sharing Statement

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

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