AzTrials
AzTrials

Pancreatic Neuroendocrine CarcinomaPhase 2OCCLURANDOMNCT02230176

Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II

A Phase 2 study testing Sunitinib and 177Lu-DOTA0-Tyr3-Octreotate in people with Pancreatic Neuroendocrine Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neuroendocrine Carcinoma
What is being tested?
Sunitinib and 177Lu-DOTA0-Tyr3-Octreotate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteFrance
Study dates
Feb 2015to Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven and reviewed well differentiated malignant pancreatic sporadic NET Metastatic disease not amenable to surgical resection
  • All target lesions (lesions measurable and non-measurable according to the RECIST 1.1 criteria), of a size ≥ 15 mm, twice the spatial resolution of the somatostatin receptor scintigraphy (SRS), should be positive (grade of uptake at SRS≥ 2, equal to the physiologic liver uptake) within 24 weeks prior to enrollment. Negative target lesions are acceptable if below 15mm.
  • Post first line whatever the type of systemic therapy: cytotoxic chemotherapy or everolimus or somatostatine analogs… Only one line of cytotoxic chemotherapy is authorized.
  • Evaluable disease according to RECIST 1.1 criteria (Appendix 2)
  • Progressing disease within 12 months prior to randomization according to RECIST 1.1 criteria ;
  • ECOG performance status 0-2 (appendix 9)
Show all 14Show fewer
  • Life expectancy ≥ 6 months as prognosticated by the physician
  • Age ≥ 18 years, no superior limit
  • Adequate bone marrow reserve (Hb > 8, neutrophils ≥ 1500/mm³ and platelets ≥80.000/mm^3)
  • Effective contraception in pre-menopausal female and male patients during and for at least 6 months post-treatment.
  • Patient´s signed written informed consent
  • Ability to comply with the protocol procedures
  • Ability to take oral medication
  • Patient affiliated to a social security system or beneficiary of the same.

Who cannot join

  • Large or small cell-poorly differentiated pancreatic neuroendocrine tumor according to WHO 2010 classification
  • Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless OctreoScan® imaging during continued Octreotide treatment is in accordance with the inclusion criteria n°2.
  • More than one line of cytotoxic chemotherapy (a patient who received the same molecules of cytotoxic chemotherapy at several times during therapeutic management is considered to have benefit from one single line of cytotoxic chemotherapy)
  • Prior external beam radiation therapy to more than 25% of the bone marrow
  • Urinary incontinence
  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least five years.
Show all 22Show fewer
  • Severe renal (measured GFR according to MDRD <50ml/mn or nephrotic syndrome) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
  • Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
  • Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN
  • Decompensated heart failure (ejection fraction <45%), myocardial infarction, stroke, pulmonary embolism or revascularization procedure,unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.
  • Hypertension that cannot be controlled despite medications (>=160/95 mmHg despite optimal medical therapy)
  • Abnormal cardiac function with 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for males or >480 msec for females.
  • Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CTscan with contrast or MRI to document stable disease prior to enrolment in the study.)
  • Pregnancy or breast feeding (see appendix 6)
  • Previous treatment with the drugs under study. Prior systemic treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors.
  • Current treatment with another investigational drug.
  • Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
  • Prior treatments with chemotherapy or immunotherapy or somatostatine analog therapy drug (except in case of functioning syndrome for somatostatine analogue therapy) or thoracic radiotherapy within 4 weeks prior to start of treatment
  • Major surgery for any cause or local radiotherapy within one month prior to start of treatment
  • Liver embolisation therapy within the last 3 months prior start of treatment except if progression is demonstrated and embolised lesion not used as targets
  • Unrecovered toxicity from any kind of therapy
  • Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration,or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

Official title: Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II.

This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.

Being tested
Sunitinib, 177Lu-DOTA0-Tyr3-Octreotate
Medical subject headings
Somatostatinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02230176
Study groupRoleWhat they receive
177Lu-DOTA0-Tyr3-Octreotate or OCLUExperimental7.4 GBq per injection (max: 4 injections)
Receives: Drug: 177Lu-DOTA0-Tyr3-Octreotate
SunitinibActive comparator37.5 mg/day
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the 12 months PFS

    Measured: Assessed 12 months after randomization

Secondary outcomes (2)

  1. Overall Survival

    Measured: Assessed every 3 months until death

  2. Best response

    According to RECIST V1.1

    Measured: Assessed every 12 weeks until progression up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionApr 2024
  4. Study completionApr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230176
Sponsor's protocol ID
2013-004032-30
Other IDs
2013/2043
Acronym
OCCLURANDOM
Status last verified
Apr 2025
First submitted
27 Aug 2014
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No

Publications

  • Baudin E, Durand A, Beron A, Smith D, Deandreis D, Taieb D, Ansquer C, Dierickx L, Deshayes E, Hentic O, Moalla S, Menu Y, Lebtahi R, Assenat E, Touchefeu Y, Guimbaud R, Dahan L, Lamartina L, Cheurfa N, Quak E, Bouhier-Leporrier K, Haissaguerre M, Hindie E, Cao CD, Lombard-Bohas C, Jannin A, Walter T, Ducreux M, Chaib S, Hadoux J, Foulon S. [177Lu]Lu-dota-tate versus sunitinib in patients with metastatic progressive neuroendocrine tumours of the pancreas (OCLURANDOM): a randomised, controlled, phase 2 trial. Lancet Oncol. 2026 Jun;27(6):699-710. doi: 10.1016/S1470-2045(26)00108-7.

    PubMed 42225102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib and 177Lu-DOTA0-Tyr3-Octreotate in people with Pancreatic Neuroendocrine Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the 12 months PFS (time frame: Assessed 12 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230176, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in