Health Condition 1: N838- Other noninflammatory disorders ofovary, fallopian tube and broad ligament
Conditions
Interventions
Intervention1: Pemetrexed and Carbopaltin: Pemetrexed 500mg/m2, I.V. and Carboplatin AUC 5, I.V. every 3 weeks total of 6 cycles followed by maintenance Pemetrexed 500mg/m2 till maximum of 4 cycles
Sponsors
CMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Woman more than or equal to 18 years old 2. Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125 divided by CEA more than 25 and pelvic mass in radiological imaging 3. Frail patients according to Frailty Deficit Index (FI) score - frailty is defined as an FI more than or equal to 0.15 4. Written informed consent obtained from subject or subject s legal representative and ability for subject to comply with the requirements of the study 5. Required initial laboratory parameters: a. Absolute Neutrophil Count more than or equal to 1,000/mm3 b. Hemoglobin greater than 10.0 g/dL c. Platelets more than or equal to 100,000/mm3 d. Total Bilirubin less than 1.5x ULN (Upper Limit of Normal) e. Serum ALT less than 2.5 x ULN f. Estimated creatinine clearance more than 60 ml/min(MDRD equation or Cockcroft Gault formula) g. PT/INR less than 1.5 x ULN
Exclusion criteria
Exclusion criteria: 1. FIGO Stage I or II 2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3.Major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study, other than that required for the ovarian cancer treatment itself 3. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer 4. Prior history of chemotherapy for the present malignancy 5. Prior history of radiotherapy which may affect patient tolerability to chemotherapy 6. Documented baseline neuropathy CTCAE v5.0 grade greater than or equal to 2 7. Patients with congestive heart failure symptomatic NYHA class greater than or equal to III 8. Pre-treatment documented LV dysfunction and/or ejection fraction less than 50% 9. Estimated creatinine clearance less than 60ml/min 10. Patients unable to be regularly followed for any reason (geographic, familial, social, psychologic) 11. Any mental or physical handicap at risk of interfering with the appropriate treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on surgical outcomes : Assess the feasibility of achieving optimal cytoreductive surgery after three cycles of chemotherapyTimepoint: after 3 chemotherapy cycles;Chemotherapy Completion Rate: Assess the proportion of patients who successfully complete all 6 planned chemotherapy cyclesTimepoint: after 6 chemotherapy cycles;Survival (OS): Evaluate the overall survival rates of patients within each treatment armTimepoint: at 3 years, 5 years;Safety and Tolerability: Monitor and evaluate the incidence and severity of treatment-related adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0Timepoint: after each chemotherapy cycles | — |
Countries
India
Contacts
Public ContactAshish Singh
Christian Medical College, Vellore
Outcome results
None listed