Health Condition 1: C56- Malignant neoplasm of ovary Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (using cisplatin plus doxorubicin): 3 cycles of
paclitaxel-carboplatin neoadjuvant chemotherapy followed by interval debulking surgery
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria at time of Registration: 1)Patients with cytopathologically and/or histopathologically proven epithelial ovarian cancer or fallopian tube or primary peritoneal cancer. 2)Patients who are planned to be treated with neoadjuvant chemotherapy followed by interval debulking surgery followed by adjuvant chemotherapy. 3)At least 18 years of age at the time of Registration in the study. 4)Patients with ECOG performance status 5)Patients with radiological evidence of stage III or IVA epithelial ovarian cancer or those with less than radiological stage III but with massive ascites requiring neoadjuvant chemotherapy. 6)Adequate hematological (defined as a white blood cell count of >=3 Ã? 10â?¹ cells per L with an absolute neutrophil count >=1·5 Ã? 10â?¹ cells per L, platelet count >=100 Ã? 10â?¹platelets per L, and haemoglobin >=8 g/dL [may have been transfused]), liver (defined as a total bilirubin concentration of 45 ml/min according to the Cockcroft-Gault formula) functions at the time of Registration. 7)Written informed consent prior to study inclusion. Inclusion Criteria after NACT up to the time of intra-operative randomization: 1)Patients who have received 3 cycles of neoadjuvant chemotherapy. Occasional patients who have received 4 cycles of NACT can also be included in the study with appropriate justification for the 4th NACT cycle. 2)Patients should have received NACT with paclitaxel (starting dose 175/m2) plus carboplatin (AUC 5-6) every 3 weeks. Dose reductions of both drugs during neoadjuvant chemotherapy because of toxicity will be allowed as per standard practice at the institution and as indicated in Table 1. Drug modification in the form of change of agent (substitution of paclitaxel with another non-platinum agent and/ or substitution of carboplaitin with cisplatin) or omission of a drug because of toxicity will be allowed at the treating physicianâ??s discretion as clinically indicated and as per standard practice at the institution. 3)Patients who have attained complete or partial response (CR or PR) after 3 (or 4) cycles of NACT. 4)Patient is considered fit for major surgery, either ASA category 1 or category 2 5)ECOG 0-2 before planned interval debulking surgery 6)Adequate hematological (defined as a white blood cell count of >=3 Ã? 10â?¹ cells per L with an absolute neutrophil count >=1·5 Ã? 10â?¹ cells per L, platelet count >=100 Ã? 10â?¹ platelets per L, and haemoglobin >=9 g/dL [may have been transfused]), liver (defined as a total bilirubin concentration of 50 ml/min according to the Cockcroft-Gault formula)functions at the time of study inclusion. 7)Not known to be pregnant.
Exclusion criteria
Exclusion criteria: Exclusion Criteria at the time of Registration 1)Patients with non-epithelial ovarian cancers. 2)Patients with early stage epithelial ovarian cancers at the time of their initial diagnosis defined as radiological stage 1 or 2, unless accompanied by massive ascites requiring neoadjuvant chemotherapy. 3)Patient with advanced epithelial ovarian cancer who undergo upfront debulking surgery as their initial treatment. 4)Current evidence of being pregnant at the time of Registration. 5)History of any previous malignancies within preceding 5 years with the exception of basal cell or squamous cell skin cancer or cervical pre-invasive neoplasia. Exclusion criteria at the time of obtaining informed consent after NACT up to the time of intra-operative randomization: 1)Patients with advanced epithelial ovarian cancer, FT or primary peritoneal cancer who do not achieve optimal interval debulking surgery (the maximum size of any residual tumor of >5 mm). 2)Patients with any contraindication to HIPEC/NIPEC 3)Patients who are not suitable for subsequent adjuvant chemotherapy after surgery. 4)Other severe acute or chronic medical conditions including cardiac, pulmonary, gastrointestinal, neurological or other disorders; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigators, would make the patient inappropriate for entry into this study. 5)Patients who are not considered reliable for follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: Progression-free survival (PFS)Timepoint: 24 months after last patient randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: 1) Overall Survival 2) Progression-free survival-serological 3) Toxicity 4) Quality of lifeTimepoint: 24 months after last patient randomization | — |
Countries
India
Contacts
Public ContactShilpa Yadav
Tata Memorial Centre
Outcome results
None listed