Neuroendocrine Tumors
Conditions
Keywords
Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor, Midgut
Brief summary
Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
Interventions
30 mg intramuscularly every 28 days
DRUGPlacebo
Sodium chloride intramuscularly every 28 days
Sponsors
Carmen Schade-Brittinger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut * curative surgery impossible * two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) * Age ≥ 18 * Karnofsky-index \> 60 * written informed consent * proliferation index for Ki67
Exclusion criteria
* hypersensitivity to octreotide * poorly differentiated or small cell neuroendocrine tumors * primary tumor outside of the midgut * prior treatment with somatostatin-analogue \> 4 weeks * prior treatment with alpha-interferon, chemotherapy, or chemoembolisation * participation in any other clinical trial * pregnancy or lactation * no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years * severe decompensated organ malfunction (heart-, liver- insufficiency) Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Up to 7 years | Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008. |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals | at 3 month intervals |
| Biochemical Response at 3 Month Intervals | at 3 month intervals up to 18 moths |
| Symptom Control at 3 Month Intervals | at 3 month intervals up to 18 moths |
| Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study | at three-month intervals |
| Survival | at least on a monthly basis |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octreotide LAR (SMS995) Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days | 42 |
| Placebo Sodium chloride intramuscularly every 28 days | 43 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Switched to Octreotide | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Octreotide LAR (SMS995) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years | 61 years | 62 years |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 42 | 11 / 43 |
| serious Total, serious adverse events | 11 / 42 | 10 / 43 |
Outcome results
Primary
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
Time frame: Up to 7 years
Population: Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octreotide LAR (SMS995) | Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | 14.3 Months |
| Placebo | Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | 6.0 Months |
Secondary
Biochemical Response at 3 Month Intervals
Time frame: at 3 month intervals up to 18 moths
Secondary
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Time frame: at 3 month intervals
Secondary
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Time frame: at three-month intervals
Secondary
Survival
Time frame: at least on a monthly basis
Secondary
Symptom Control at 3 Month Intervals
Time frame: at 3 month intervals up to 18 moths