Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: cisplatin 75mg/m2 intraperitoneally (IP): Intraoperative NIPEC protocol (ONLY Arm A) will consist of cisplatin 75mg/m2 intraperitoneally (IP), which will be instilled with the help of i
Sponsors
BBCIDr B Borooah Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1) 20 years to 70 years. 2) Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma). 3) Pre-therapy FIGO (International Federation of Gynaecology and Obstetrics) stage IIIC (clinical). 4) Patient eligible for Interval Cytoreductive Surgery (ICS) after neo-adjuvant chemotherapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks. 5) WHO (World Health Organization) performance status less than 2. 6) Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery. 7) Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products. 8) Patient is willing to participate and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up. 9) Signed written informed consent. 10) Residual disease after surgery (cytoreduction score CC) CC 0 (no macroscopic residue) or CC 1 11) Per-operative haemorrhage less than2 L 12) Diuresis maintained during surgery, without oliguria or anuria .
Exclusion criteria
Exclusion criteria: 1) Benign disease, borderline disease, non-epithelial ovarian carcinoma or carcinosarcoma. 2) Decompensated liver disease. 3) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 4) Auditory impairment 5) Disease that contraindicates hyper hydration (including cardio-respiratory disease). 6) Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhoea) chronic disease. 7) Any unresolved NCI-CTCAE grade = 2 toxicity from previous anticancer therapy (excluding alopecia). 8) Concomitant treatment with prophylactic phenytoin. 9) Bowel resection anastomosis. 10) Receipt of live attenuated vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment). 11) Pregnant or breast feeding woman. 12) Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent. 13) Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons). 14) Person under guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Progression-free Survival (PFS) [Time frame: from randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 2 years. (Follow-up up to 5 years)]Timepoint: 1)Progression-free Survival (PFS) will be assessed at baseline, 1 year and 2 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival [Time Frame: From date of randomization to the date of death or date of last follow up].Timepoint: 2 years follow up will be done for OS | — |
Countries
India
Contacts
Public ContactUpasana Baruah
Dr B Borooah Cancer Institute
Outcome results
None listed