Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Cap. Carctol-S: 1-gm 3 times a day (Total dose3g/day) until disease progression or drug intolerance or one year
whichever earliest.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Central Council for Research in Ayurvedic Sciences Ministry of AYUSH Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with high grade serous ovarian cancer who attained complete response to front line treatment and experienced first serological relapse. 2.European Cooperative Oncology Group (ECOG) Performance score is less than or equal to 1. 3.No evidence of disease on clinical examination. 4.No or minimal disease on CE-CT (abdomen, pelvis and thorax)
Exclusion criteria
Exclusion criteria: 1.Symptomatic patients. 2.Patients with evidence of disease on clinical examination. 3.Patients with evidence of significant disease on radiological imaging. 4.Patients who did not attain CR to frontline primary treatment. 5.Inability to follow up at regular intervals. 6.Inability to take oral medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in terms of Complete Response or Partial Response or Stable Disease Timepoint: 12 weeks after receiving the first dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug related toxicity graded according to NCI CTCAE version 4.03 and the quality of life of patients using EORTC QLQ C-30 and EORTC QLQ-OV28 Timepoint: At baseline and at 12 weeks, 24 weeks, 36 weeks and 48 weeks after starting the treatment | — |
Countries
India
Contacts
Public ContactDr Manohar S Gundeti
Tata Memorial Centre
Outcome results
None listed