| Protocol ID | NCT01200121 |
| Registration Date | 2010-09-13 |
| Status | completed |
| Sponsor | AIO-Studien-gGmbH |
| Country | Germany |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2010-02-01 |
| Last Patient Out | 2014-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT01200121
Double-blind, Placebo-controlled, Randomized Phase II-study Investigating the Efficacy of Bevacizumab for Symptom Control in Patients With Malignant Ascites Due to Advanced-stage Gastrointestinal Cancers
| Field |
OPENAI
gpt-4o Thinking: o3 2914ms / 10353 tok |
GLM
glm-5.1 6842ms / 10527 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5343ms / 12123 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
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The intervention, consisting of intraperitoneal infusions of Bevacizumab, involves procedures such as paracentesis that do not necessarily require inpatient hospitalization but can be administered in an outpatient setting.
|
outpatient
outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The intervention involves patients visiting a clinic for repeated intraperitoneal infusions every 14 days over an 8-week treatment period, indicating they are not continuously hospitalized.
|
outpatient
inpatient → outpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: outpatient — The study involves intraperitoneal administration of bevacizumab/placebo through paracentesis procedures, which are typically performed as outpatient procedures where patients come to clinic for treatment but are not admitted overnight.
|
OK |
| setting_place |
hospital
other → hospital
shaky reasoning✓ Unanimous
Initial: other
Requery: hospital — The intervention involves repeated intraperitoneal administrations of Bevacizumab, which are typically performed in a medical facility with appropriate monitoring and capabilities, suggesting the primary setting is a hospital.
|
hospital
hospital
shaky reasoning✓ Unanimous
Initial: hospital
|
hospital
hospital → hospital
shaky reasoning✓ Unanimous
Initial: hospital
Requery: hospital — The intervention involves intraperitoneal infusions of bevacizumab after paracentesis procedures, which require specialized medical facilities and inpatient care typically found in hospital settings.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio |
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The tested intervention, Bevacizumab, is an angiogenesis inhibitor and not classified as chemotherapy, immunotherapy, or radiation therapy.
Thinking: no — The intervention is bevacizumab, an anti-VEGF targeted antibody, which is neither chemotherapy, a checkpoint-inhibitor/CAR-T immunotherapy, nor radiation therapy.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The active intervention being tested is Bevacizumab, which is a targeted monoclonal antibody (anti-VEGF), and therefore does not fall under the specified categories of chemotherapy, immunotherapy, or radiation therapy.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — Bevacizumab is an immunotherapy agent (monoclonal antibody targeting VEGF) being tested as the active intervention in this trial.
Thinking: no — Bevacizumab is a monoclonal antibody targeting VEGF for symptom control, not chemotherapy, checkpoint inhibitor immunotherapy, CAR-T therapy, or radiation therapy.
|
OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial tests the efficacy of Bevacizumab, a drug, for symptom control in malignant ascites, not palliative care as an intervention.
|
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is testing bevacizumab (a drug) for symptom control in cancer patients, not palliative care consultation or service delivery.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The trial focuses on symptom control for malignant ascites, which is a direct symptom assessment related to the condition, thus classifying it under outcome_symptom as 'yes'.
Thinking: no — The endpoints track paracentesis-free survival and quality-of-life questionnaires but do not use any validated symptom scales such as pain, nausea, ESAS, etc.
|
yes
yes
shaky reasoning✗ No consensus
Initial: yes
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — The primary outcome measures paracentesis-free survival and secondary outcomes focus on ascites volume, quality of life, performance status, and safety measures, but no validated symptom assessment instruments are mentioned.
Thinking: yes — The primary outcome (paracentesis-free survival) directly measures symptom control of malignant ascites, as paracentesis is performed for symptom relief.
|
|
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
immunotherapy
other → immunotherapy
shaky reasoning✓ Unanimous
Initial: other
Requery: immunotherapy — Bevacizumab is a monoclonal antibody used in the treatment of certain cancers, fitting the category of immunotherapy.
|
immunotherapy
off label use → immunotherapy
shaky reasoning✓ Unanimous
Initial: off label use
Requery: immunotherapy — Bevacizumab is a monoclonal antibody, which falls under the immunotherapy classification for cancer treatment.
|
immunotherapy
other → immunotherapy
shaky reasoning✓ Unanimous
Initial: other
Requery: immunotherapy — Bevacizumab is a monoclonal antibody targeting VEGF used for cancer treatment, which classifies it as immunotherapy.
|
OK |