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Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

Primary Purpose

Neuroendocrine Tumors

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

[177Lu] DOTA-TATE

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Neuroendocrine Tumors, Lutetium, Treatment Outcome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with inoperable gastroenteropancreatic neuroendocrine tumors.
Histopathologic diagnosis confirmed at the Instituto Nacional de Cancerología.
Somatostatin receptor-positive tumors with at least one site of abnormal focal uptake > liver physiologic uptake (3+) observed in a 99mTc-HYNIC-TOC scintigraphy practiced less than 6 months before treatment with 177Lu- DOTATATE.
Karnofsky functional score > 60.
Life expectancy > 3 months.
Multiple inoperable metastatic sites.
Patient voluntarily willing to participate in the trial.
Hemoglobin (Hb) > 8.8 g/dl
Leucocytes (Leu) > 2 x 103/µl
Platelets (Plaq) > 80 x 103/µl
Total Bilirrubin (BT) ≤ 3 times the upper limit of normal range. Serum albumin > 3 g/dl and normal prothrombin time.
At least one measurable CT tumor lesion.
Non-lactating woman with negative pregnancy blood test.
Creatinine clearance > 40 ml/min and serum creatinine < 1.5 mg/dl and/or isotopic glomerular filtration rate > 50 ml/min.
Test results should predate treatment by at least: blood test results ≤ 4 weeks, liver blood tests < 1 month, renal function tests < 1 week, CT ≤ 4 months and 99mTc-HYNIC-TOC scintigraphy < 6 months.

Exclusion Criteria:

Patients previously treated with radionuclide therapy.
Patients treated with chemo- o radiotherapy within the past 6 months.
Patients unable to comply with clinical follow-up in both Nuclear Medicine and Endocrinology units.
Patients unwilling to participate in the trial or not providing written informed consent.

Sites / Locations

Instituto Nacional de Cancerología

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[177Lu] DOTA-TATE

Arm Description

We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.

Outcomes

Primary Outcome Measures

Response to treatment

Response to palliative treatment with 177Lu- DOTATATE in patients with metastatic progressive low-grade neuroendocrine tumors defined by control size tumor, response time to reduction minimal parcial and complete tumor.

Secondary Outcome Measures

Efficacy defined by reduction in size tumoral

Measure the efficacy of 177Lu- DOTATATE to treat patients with metastatic progressive low-grade neuroendocrine tumors using clinical and imaging criteria such as tumor size.

Side effects defined by clinical follow up

Describe the side effects of the treatment with 177Lu- DOTATATE by clinical follow-up during and after therapy

survival rate

describe the 2-year survival rate of patients treated with 177Lu- DOTATATE

Quality of life

Assess the quality of life of patients with metastatic progressive low-grade neuroendocrine tumors treated with 177Lu- DOTATATE during treatment defined by pain reduction and tolerability.

Full Information

NCT ID

NCT02125474

First Posted

April 22, 2014

Last Updated

November 12, 2019

Sponsor

Instituto Nacional de Cancerologia, Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02125474

Brief Title

Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

Official Title

Efficacy of Peptide Receptor Radionuclide Therapy for Metastatic Inoperable Neuroendocrine Tumors Using 177-Lu-DOTA 0, Tyr 3 Octreotate

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto Nacional de Cancerologia, Columbia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing number of new cases reported in the annual statistics of the Instituto Nacional de Cancerología (INC). The majority are advanced-stage presentations with limited chances of a complete surgical resection of the primary tumor, a clinical scenario where medical treatment options are also limited. In view of the characteristically defined expression of peptide receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have been designed using radioisotopes with short range of penetration in tissues. We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET. Selected patients matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor response, treatment safety (side effects) and survival will be appraised. Data from clinical, biochemical and imaging follow-up will be periodically registered during treatment and until two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified because despite the fact that many preclinical and clinical studies have showed the potential usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its efficacy as first-line treatment.

Detailed Description

The Investigators have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.

6. Conditions and Keywords

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

Neuroendocrine Tumors

Keywords

Neuroendocrine Tumors, Lutetium, Treatment Outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[177Lu] DOTA-TATE

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

[177Lu] DOTA-TATE

Intervention Description

Primary Outcome Measure Information:

Title

Response to treatment

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Efficacy defined by reduction in size tumoral

Description

Measure the efficacy of 177Lu- DOTATATE to treat patients with metastatic progressive low-grade neuroendocrine tumors using clinical and imaging criteria such as tumor size.

Time Frame

3 years

Title

Side effects defined by clinical follow up

Description

Describe the side effects of the treatment with 177Lu- DOTATATE by clinical follow-up during and after therapy

Time Frame

5 years

Title

survival rate

Description

describe the 2-year survival rate of patients treated with 177Lu- DOTATATE

Time Frame

2 years

Title

Quality of life

Description

Assess the quality of life of patients with metastatic progressive low-grade neuroendocrine tumors treated with 177Lu- DOTATATE during treatment defined by pain reduction and tolerability.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with inoperable gastroenteropancreatic neuroendocrine tumors. Histopathologic diagnosis confirmed at the Instituto Nacional de Cancerología. Somatostatin receptor-positive tumors with at least one site of abnormal focal uptake > liver physiologic uptake (3+) observed in a 99mTc-HYNIC-TOC scintigraphy practiced less than 6 months before treatment with 177Lu- DOTATATE. Karnofsky functional score > 60. Life expectancy > 3 months. Multiple inoperable metastatic sites. Patient voluntarily willing to participate in the trial. Hemoglobin (Hb) > 8.8 g/dl Leucocytes (Leu) > 2 x 103/µl Platelets (Plaq) > 80 x 103/µl Total Bilirrubin (BT) ≤ 3 times the upper limit of normal range. Serum albumin > 3 g/dl and normal prothrombin time. At least one measurable CT tumor lesion. Non-lactating woman with negative pregnancy blood test. Creatinine clearance > 40 ml/min and serum creatinine < 1.5 mg/dl and/or isotopic glomerular filtration rate > 50 ml/min. Test results should predate treatment by at least: blood test results ≤ 4 weeks, liver blood tests < 1 month, renal function tests < 1 week, CT ≤ 4 months and 99mTc-HYNIC-TOC scintigraphy < 6 months. Exclusion Criteria: Patients previously treated with radionuclide therapy. Patients treated with chemo- o radiotherapy within the past 6 months. Patients unable to comply with clinical follow-up in both Nuclear Medicine and Endocrinology units. Patients unwilling to participate in the trial or not providing written informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen A De los Reyes, Md

Organizational Affiliation

Instituto Nacional de Cancerología

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Cancerología

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

00000

Country

Colombia

12. IPD Sharing Statement

Learn more about this trial

Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

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