| Protocol ID | NCT00358566 |
| Registration Date | 2006-08-01 |
| Status | Terminated |
| Sponsor | Pharmexa A/S |
| Country | Australia, Belgium, Denmark, France, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, United States |
| Industry | industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | multinational RCT |
| First Patient In | 2006-06-01 |
| Last Patient Out | 2008-08-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 75 Years |
NCT00358566
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
| Field |
GLM
glm-5.1 7066ms / 8918 tok |
CLAUDE
claude-sonnet-4-20250514 4991ms / 10241 tok |
OPENAI
gpt-4o 2246ms / 8765 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The trial involves outpatient chemotherapy and immunotherapy administration for advanced pancreatic cancer, which is typically delivered in outpatient clinic settings rather than requiring hospital admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is a multinational, multicentre trial with 86 sites delivering chemotherapy and biological treatments to advanced pancreatic cancer patients, which would typically be administered in outpatient oncology clinics rather than requiring inpatient hospitalization.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention involves outpatient administration of chemotherapy drugs in a multicenter setting without specifying hospital admission.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | yes | yes | yes | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves only a sequential pharmacologic/biologic treatment regimen using drugs (GV1001, GM-CSF, and gemcitabine), which constitutes a single-modality intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a sequential combination of two pharmacologic agents (GV1001 peptide vaccine plus GM-CSF followed by gemcitabine), which represents a single treatment modality rather than multiple interacting components from different categories.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial primarily combines a biological treatment (GV1001) with a drug (Gemcitabine) in sequence, which does not constitute a complex intervention as it remains within a pharmacological approach.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
immunotherapy
immunotherapy → immunotherapy
shaky reasoning✓ Unanimous
Initial: immunotherapy
Requery: immunotherapy — GV1001 is an investigational therapeutic cancer vaccine (a peptide vaccine targeting telomerase), which represents a biological immunotherapy approach used here for the treatment of advanced pancreatic cancer.
|
immunotherapy
immunotherapy → immunotherapy
shaky reasoning✓ Unanimous
Initial: immunotherapy
Requery: immunotherapy — GV1001 is a telomerase-based cancer vaccine (biological immunotherapy) used in combination with gemcitabine chemotherapy for cancer treatment.
|
immunotherapy
chemotherapy → immunotherapy
shaky reasoning✓ Unanimous
Initial: chemotherapy
Requery: immunotherapy — GV1001 is a peptide vaccine used in combination with GM-CSF, indicating an immunotherapy approach for cancer treatment.
|
OK |