| Protocol ID | NCT00916578 |
| Registration Date | 2009-06-09 |
| Status | completed |
| Sponsor | M.D. Anderson Cancer Center |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2009-06-05 |
| Last Patient Out | 2017-06-06 |
| Publication | y |
| Gender % | FEMALE |
| Mean Age | 18 Years - |
NCT00916578
A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5350ms / 10512 tok |
GLM
glm-5.1 7923ms / 9224 tok |
OPENAI
gpt-4o Thinking: o3 2878ms / 9056 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | 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 | hospital | hospital | hospital | OK |
| feasibility |
fully powered RCT
fully powered RCT → fully powered RCT → fully powered RCT
shaky reasoning✗ No consensus
Initial: fully powered RCT
Requery: fully powered RCT — This is a Phase II single-arm study with n=33 enrollment designed to evaluate response rate as the primary clinical outcome, not feasibility parameters.
Thinking: fully powered RCT — Phase II study with clinical primary outcome (response rate) designed to enroll up to 60 patients for effectiveness assessment.
|
N/A |
feasibility RCT
feasibility RCT → N/A → N/A
shaky reasoning✗ No consensus
Initial: feasibility RCT
Requery: N/A — The study is a Phase II interventional trial, not an RCT, focused on assessing treatment response rather than recruitment or feasibility.
Thinking: N/A — Single-arm Phase II trial without randomization, so it is not an RCT.
|
|
| 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 | yes | no | yes | – |
| 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 |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary outcome measures only response rate (tumor response) which falls under symptom/disease control categories typically assessed in cancer trials.
|
yes |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes focus on response rate, a direct measure of treatment impact on cancer, fitting into efficacy assessment related to symptoms and survival.
|
– |
| pharmacologic_sub | chemotherapy | chemotherapy | chemotherapy | OK |