Octreotide LAR as Maintenance Treatment for Patients With NEC

What Was Tested

The trial (phase 2) is built around Octreotide.

It had two arms (groups): control group (no intervention) and Octreotide LAR treatment (experimental).

The patients with unresectable or metastatic GEP or esophageal NEC who got CR/PR/SD after chemotherapy with IP or EP regimen qualified with the inclusion criteria are enrolled. All the patients enrolled in their study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression.

The registry classes the interventions as drug.

More on the Plan

All the patients enrolled in their study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression.

Treatment will be discontinued on withdrawal of patient consent, disease progression, unacceptable toxicity, a treatment delay of \>2 weeks, or major protocol violations, after which patients were followed up every 3 months for a minimum of 12 months.

Who Took Part

Enrollment: 92 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma. High grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded). Metastatic or unresectable disease. Accepted chemotherapy with EP or IP regimen for no less than three months. Performance status of 0 or 1.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: patients who are on ep or ip chemotherapy for less than three months ; patients with brain metastases are not eligible; patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-04 with completion listed for 2018-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PFS (time frame: 3 years).

It also tracked 1 secondary outcome, for example OS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 92 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.