IPO-NEC Trial:Study on the Efficacy and Safety Using Sequential IP Therapy and Oct Lar in the Treatment of Advanced GI NEC

What Was Tested

The trial (phase 2) is built around Octreotide.

Patient with written consents will enter the phase one step of the trial, receiving IP therpy.

Once the IP therapy has been finished without disease progression or progression occurs during the treatment, the patient will enter the phase two step of the trial, receiving octreotide treatment.

It had 1 arm (groups): Treatment arm (experimental).

This is a single arm trial. The patient will enter phase one and will continue to phase two once the disease progresses in phase one or the phase one has been completed.

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Written Informed consent. Male or female patients \>=18 years old. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma originating from the GI tract. The grade of the disease is grade 2 or grade 3. Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment. The laboratory parameter meets the following criteria 7 days before enrollment.

The full record lists 15 inclusion and 15 exclusion criteria; among the exclusions: known sensitivity to 5-ht3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar; any participation in trials simultaneously or 4 weeks before screening; undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-09 with completion listed for 2012-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression Free Survival for Irinotecan plus cisplatin and octreotide (time frame: 2 years).

It also tracked 3 secondary outcomes, for example Disease control rate, Overall survival and Safety.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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