Methods | Study duration: April 1986 to February 1990. Type of trial: Multicentre RCT, intention-to-treat analysis. |
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Participants | Stage II-IV (except unresectable stage IV diseases). Performance status ECOG: at least 2. Histology proven, with exclusion of borderline tumour. Primary surgery must be performed through an appropriate incision/ a maximal attempt to remove tumours. Residual disease status > 2 cm. No evidence of progressive disease, extraperitoneal tumour > 1 cm, or had excessive delay after induction chemotherapy and before randomisation Baseline characteristics (N = 86): 24 women aged <50, 25 between 50 - 60, and 30> 60 years. 50 women had performance status 0 or 1, 20 status 2 and 9 women had status 3 or 4. 6 women were diagnosed with FIGO stage IIB, 62 stage III and 11 had stage IV disease. 39 women had residual disease between 2 - 5 cm, 29 between 5 - 10 cm and 11 >10 cm. Histology type was as follows: Serous 32, mucinous 6, endometroid 13, clear cell 4, undifferentiated 6 and unspecified 20. Histology differentiation was as follows: Poor 37, moderate 27, well 6 and unspecified 9 |
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Interventions |
Intervention: IDS: after 1 - 4 cycles of induction chemotherapy consisting of IV cisplatin 75 mg/m2 + cyclophosphamide 750 mg/m2 or cisplatin 75 mg/m2 + doxorubicin 50 mg/m2 + bleomycin 50 mg/m2 followed by escalated dose of cyclophosphamide (0.5 g/m2-2.5 g/m2) up to 5 cycles. Chemotherapy cycles were repeated every 3 weeks. Control: No IDS: the same regimen of chemotherapy was given in a row every 3 weeks |
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Outcomes | Overall survival (OS). Perioperative complications: primary haemorrhage, blood transfusion, deep vein thrombosis, intestinal fistula, postoperative febrile morbidity, postoperative ileus |
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Notes | Randomised at entry (within 4 weeks after primary surgery). Number ineligible: 7 (primary surgery was not suboptimal). Only 9% of primary surgeons were gynaecologic oncologists. IDS performed by the primary surgeon. Response evaluation by physical examination, imaging studies (CA125 not used). OS was measured from the date of entry. Rate of complications was described only in the IDS group. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Randomisation sheets were produced by the random permuted blocks methods utilising the NAG Fortran Library subroutine to generate random numbers” |
Allocation concealment (selection bias) | Low risk | “These preprinted sheets were kept at the trial’s office and medical personnel were given no access to them” |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | N analysed: 79/86 (92%) |
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 |