NCT03174275 · OUTCOME
Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- After surgery (approximately 8-12 weeks after start of study treatment)
What was measured
The pCRR was assessed via surgical pathology report. Pathologic complete response will require no viable cancer cells on the surgical pathology report after neoadjuvant treatment with carboplatin, nab-paclitaxel, and durvalumab. This study protocol requires the same neoadjuvant therapy and surgery for all subjects. The primary outcome measure is the complete pathologic response defined by the surgical pathology report and is unrelated to adjuvant therapy.
Analysis population: Subjects received treatment in 4 cancer centers in the United States.
Groups in this outcome
Pathologic Complete Response
All subjects received neoadjuvant chemotherapy and underwent surgery, and histopathological analyses were completed.
| Group | Source count |
|---|---|
| Pathologic Complete Response | 35 |
Reported measurements
Pathologic complete response was achieved
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pathologic Complete Response | 10 | Not reported | Not reported | Not reported | Not reported |
Pathologic complete response was not achieved
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pathologic Complete Response | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Pathologic complete response was achieved
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- Pathologic complete response was not achieved
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- The pCRR was assessed via surgical pathology report. Pathologic complete response will require no viable cancer cells on the surgical pathology report after neoadjuvant treatment with carboplatin, nab-paclitaxel, and durvalumab. This study protocol requires the same neoadjuvant therapy and surgery for all subjects. The primary outcome measure is the complete pathologic response defined by the surgical pathology report and is unrelated to adjuvant therapy.
- groups
- description
- All subjects received neoadjuvant chemotherapy and underwent surgery, and histopathological analyses were completed.
- id
- OG000
- title
- Pathologic Complete Response
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Subjects received treatment in 4 cancer centers in the United States.
- reporting Status
- POSTED
- time Frame
- After surgery (approximately 8-12 weeks after start of study treatment)
- title
- Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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