TriangleNCT00525785 · OUTCOME
Complete Pathologic Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment
What was measured
The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
Groups in this outcome
5-Fluorouracil + Folinic Acid + Oxaliplatin
FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid \& infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2 for 5 days) \& weekly oxaliplatin 45 mg/m\^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
| Group | Source count |
|---|---|
| 5-Fluorouracil + Folinic Acid + Oxaliplatin | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5-Fluorouracil + Folinic Acid + Oxaliplatin | 14 | Not reported | 6 | 25 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6
- upper Limit
- 25
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 58
- units
- Participants
- description
- The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid \& infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2 for 5 days) \& weekly oxaliplatin 45 mg/m\^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
- id
- OG000
- title
- 5-Fluorouracil + Folinic Acid + Oxaliplatin
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment
- title
- Complete Pathologic Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice