JCOG0607
A non-randomized confirmatory trial of an expanded indication for endoscopic submucosal dissection for intestinal-type gastric cancer (cT1a): the Japan Clinical Oncology Group study (JCOG0607)
N = 470
- Population
- Patients with cT1a intestinal-type gastric adenocarcinoma beyond the earlier endoscopic-resection criteria (ulcer-negative lesions larger than 2 cm; ulcer-positive lesions up to 3 cm); median tumour size 25 mm.
- Design
- Single-arm confirmatory trial in 29 institutions (June 2007 to October 2010). Eligibility: endoscopically diagnosed cT1a single intestinal-type adenocarcinoma, any-size ulcer-negative or 3 cm or smaller ulcer-positive lesion, cN0M0. Noncurative ESD was followed by surgery. Primary endpoint 5-year overall survival, planned sample 470, with a threshold 5-year OS of 86.1% (one-sided alpha 2.5%). No registry identifier appears in the abstract.
- Primary endpoint
- OS
- Arms
- Endoscopic submucosal dissection (expanded criteria) (experimental, n = 470): ESD, with added surgical resection if resection was noncurative
- People
- Hasuike N
Show the numbers
| Endpoint | Analysis | Endoscopic submucosal dissection (expanded criteria) | Control | Effect |
|---|---|---|---|---|
| OSAll enrolled patients (470) | primaryGastrointestinal 2018 | 97% at 5 y (95.0–98.2%) | — | Single-arm trial: the comparison is with a prespecified threshold of 86.1%, not a control arm. |
| En bloc resection rateAll enrolled patients (470) | primaryGastrointestinal 2018 | 99.1% | — | — |
| Endpoint | Analysis | Endoscopic submucosal dissection (expanded criteria) | Control | Effect |
|---|---|---|---|---|
| OSAll enrolled patients (470) | primaryGastrointestinal 2018 | 97% at 5 y (95.0–98.2%) | — | Single-arm trial: the comparison is with a prespecified threshold of 86.1%, not a control arm. |
| En bloc resection rateAll enrolled patients (470) | primaryGastrointestinal 2018 | 99.1% | — | — |
Appears in
Sources
Gastrointestinal Endoscopy Group of Japan Clinical Oncology Group (JCOG-GIESG), Hasuike N, Ono H, Boku N, Mizusawa J, Takizawa K, Fukuda H, et al. A non-randomized confirmatory trial of an expanded indication for endoscopic submucosal dissection for intestinal-type gastric cancer (cT1a): the Japan Clinical Oncology Group study (JCOG0607). Gastric Cancer. 2018;21(1):114-123.