| Methods |
Study duration: March 1987 to May 1993.
Type of trial: Multicentre RCT, intention‐to‐treat analysis. |
| Participants |
Stage IIB‐IV.
Age of participants < 75 years.
Performance status WHO: 0‐2.
Primary surgery performed within 6 weeks before induction chemotherapy.
Histology proven, with central pathologic review.
Residual disease status > 1 cm.
Have some response or stable disease after induction chemotherapy without evidences of progressive diseases or had contraindication to surgery.
Baseline characteristics (N = 319):
Median age was 59 years in both groups (range: 32 ‐ 74).
68 women had performance status 0, 99 status 1, and 33 status 2.
10 women were diagnosed with FIGO stage IIB, 146 stage III and 44 had stage IV disease.
10 women had residual disease between 1 ‐ 2 cm, 45 between 2 ‐ 5 cm, 44 between 5 ‐ 10cm, 60 >10 cm and 41 unknown but > 2 cm.
Histology type was as follows: Serous 115, mucinous 12, endometroid 17, clear cell 5, and unclassified 51.
Histology grade was as follows: 1: 17, 2: 59, 3: 105 and unknown: 9. |
| Interventions |
Intervention:
IDS: after 3 cycles of induction chemotherapy composing of IV cyclophosphamide 750 mg/m² + IV 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.
Perioperative complications: bowel injury, urinary bladder injury, blood loss, postoperative fever, ileus, urinary tract infection, wound infection, deep vein thrombosis, lung embolism.
Clinical response rate after 6 cycles of chemotherapy. |
| Notes |
Randomised after 3 cycles of induction chemotherapy at Central EORTC data centre, after stratification with a minimization technique to account for institution, performance status, and clinical response.
Number ineligible: 4
Response evaluation by WHO response criteria.
Consolidation chemotherapy after 6 cycles was allowed based on institutions policy.
Survivals were measured from the first date of chemotherapy (after enrolment).
Rate of complications was detailed only in the IDS group |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Randomization was done ... after stratification with a minimization technique to account for institution, performance status, and clinical response" |
| Allocation concealment (selection bias) |
Low risk |
"Randomization was done centrally at the EORTC Data Center" |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
N analysed: 278/319 (87%) |
| 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 |
