EORTC 55971
Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer
Phase 3N = 670NCT00003636
- Population
- Stage IIIC or IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma; 632 of the patients randomly assigned were eligible and started treatment.
- Design
- Randomised comparison of primary debulking surgery followed by platinum-based chemotherapy with neoadjuvant platinum-based chemotherapy followed by interval debulking surgery. The name EORTC 55971 (the organisation study ID on ClinicalTrials.gov, not an acronym) and the phase are taken from the ClinicalTrials.gov record NCT00003636 (not stated in the abstract).
- Arms
- Primary debulking surgery (control): Primary debulking surgery followed by platinum-based chemotherapy
- Neoadjuvant chemotherapy (experimental): Neoadjuvant platinum-based chemotherapy followed by interval debulking surgery
- People
- Vergote I
OSHR 0.98Progressive diseaseHR 1.01Δ Residual tumour of 1 cm or less+39 points
Show the numbers
| Endpoint | Analysis | Neoadjuvant chemotherapy | Primary debulking surgery | Effect |
|---|---|---|---|---|
| OSIntention-to-treat analysis, as stated in the abstract (670 patients randomly assigned) | primaryVergote 2010 | — | — | HR 0.98P=0.01 for noninferiorityHazard ratio for death with neoadjuvant chemotherapy followed by interval debulking surgery versus primary debulking surgery followed by chemotherapy. The abstract gives a 90% confidence interval of 0.84 to 1.13 (not a 95% interval), so none is entered in the interval field. The abstract does not give median survival times. |
| Progressive diseaseNot stated in the abstract (the hazard ratio for death is labelled intention-to-treat) | primaryVergote 2010 | — | — | HR 1.01Hazard ratio for progressive disease, neoadjuvant chemotherapy versus primary debulking surgery; 90% confidence interval 0.89 to 1.15 as stated in the abstract. |
| Residual tumour of 1 cm or lessPatients who had debulking surgery (denominators not stated in the abstract)Share of patients whose largest residual tumour was 1 cm or less in diameter after primary debulking surgery or after interval debulking surgery. | primaryVergote 2010 | 80.6% | 41.6% | — |
| Endpoint | Analysis | Neoadjuvant chemotherapy | Primary debulking surgery | Effect |
|---|---|---|---|---|
| OSIntention-to-treat analysis, as stated in the abstract (670 patients randomly assigned) | primaryVergote 2010 | — | — | HR 0.98P=0.01 for noninferiorityHazard ratio for death with neoadjuvant chemotherapy followed by interval debulking surgery versus primary debulking surgery followed by chemotherapy. The abstract gives a 90% confidence interval of 0.84 to 1.13 (not a 95% interval), so none is entered in the interval field. The abstract does not give median survival times. |
| Progressive diseaseNot stated in the abstract (the hazard ratio for death is labelled intention-to-treat) | primaryVergote 2010 | — | — | HR 1.01Hazard ratio for progressive disease, neoadjuvant chemotherapy versus primary debulking surgery; 90% confidence interval 0.89 to 1.15 as stated in the abstract. |
| Residual tumour of 1 cm or lessPatients who had debulking surgery (denominators not stated in the abstract)Share of patients whose largest residual tumour was 1 cm or less in diameter after primary debulking surgery or after interval debulking surgery. | primaryVergote 2010 | 80.6% | 41.6% | — |