| Methods |
Study duration: June 1994 to January 2001.
Type of trial: Multicentre RCT, intention‐to‐treat basis. |
| Participants |
Stage III‐IV (malignant pleural effusion or a resected anterior abdominal wall tumour) (exclusion of stage IV after March 1996 after EORTC reported a greater benefit from secondary surgery after the exclusion of such patients from the analyses).
Age < 75 years
Performance status ACOG: 0 ‐ 2 with life expectancy of at least 8 weeks.
Primary surgery performed within 6 weeks before chemotherapy.
Primary surgery aimed to remove as much as possible.
Histology proven, with central pathologic review.
Residual disease status > 1 cm.
Had no delay of chemotherapy treatment > 2 weeks.
Baseline characteristics (N = 448):
Median age 58.1 (range: 25.4 ‐ 81.6 years) in the IDS group and 57 (range: 27‐81.6 years) in the no IDS group.
166 women had GOG performance status 0, 227 had status 1 and 31 women had status 2.
400 women were diagnosed with FIGO stage III and 24 had stage IV disease.
297 women had measurable disease.
53 women had residual disease between 1 ‐ 2 cm, 183 between 2.1 ‐ 5 cm, 150 between 5.1 ‐ 10 cm and 38 >10 cm.
Histology type was as follows: Serous 324, mucinous 3, endometroid 28, clear cell 7, mixed epithelial 37, adenocarcinoma (unspecified) 12 and undifferentiated or other 13.
Histology grade was as follows: 1: 40, 2: 167, 3 or clear cell: 217 |
| Interventions |
Intervention:
IDS: after 3 cycles of chemotherapy consisting of IV paclitaxel 135 mg/m² + cisplatin 75 mg/m² every 3 weeks. Three more cycles of the same chemotherapy regimen were given after IDS.
No IDS: the same regimen of chemotherapy was given in a row every 3 weeks for 6 cycles. |
| Outcomes |
Overall survival.
Progression‐free survival.
Adverse effects: peripheral neuropathy, haematologic effects, gastrointestinal events, pulmonary events, cardiovascular events, and cause of death.
Quality of life. |
| Notes |
Randomised after 3 cycles of chemotherapy.
Number ineligible: 24
Majority of surgeons for primary and secondary surgery (IDS) were gynaecologic oncologists.
Response evaluation by physical examination, imaging studies, and CA125.
Consolidation chemotherapy was allowed.
Overall and progression‐free survival were measured from the date of randomisation and also from the date of enrolment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
N analysed: 424/448 (95%) |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement |
| Other bias |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
