Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Prospective Interventional - single institution feasibility study: 1. Initial Chemotherapy
(a) Injection Paclitaxel 175 mg per square meter in 500 ml normal saline over three hours intr
Sponsors
Younus Mondal
Institute of Post Graduate Medical Education and Research Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: Participants must fulfill all of the following criteria to be eligible for the study: Histopathological confirmation: Carcinoma Cervix (Squamous Cell Carcinoma). Age: 18.00 years (equivalent to 6,570 days) to 65.00 years (equivalent to 23,725.00 days). Sex: Female. Baseline Hematologic Parameters: a. Hemoglobin greater than or equal to 10.00 grams per deciliter. b. Total Leukocyte Count greater than or equal to 1,500.00 cells per cubic millimeter. c. Platelet Count greater than or equal to 100,000.00 per cubic millimeter. Stage of Disease: FIGO Stage IIB, III, or IVA. Liver Function Tests: a. Total Bilirubin less than or equal to 2.00 times the upper normal limit. b. SGOT and SGPT less than or equal to 3.00 times the upper normal limit. Renal Function: a. Estimated Creatinine Clearance greater than or equal to 50.00 milliliters per minute, calculated using the Cockcroft-Gault or MDRD formula.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: Presence of any other solid tumor within the past five years except skin melanoma treated with local therapy only. Prior pelvic radiotherapy for any indication. Presence of vesicovaginal fistula or rectovaginal fistula at presentation, either radiologically or clinically. History of or current uncontrolled co-morbid conditions which, in the opinion of the investigator, would compromise the safety of the patient. Known contraindications to radiotherapy. Any disease where para-aortic nodal irradiation is considered the standard of care. Known allergies or hypersensitivity reactions to platinum-based drugs, taxanes, arachis oil, or any other drugs to be administered in the study protocol schedule. Pregnant or lactating women. Patients unable to provide informed consent or comply with the follow-up protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and radiological response rates at the first follow-up would be reported as descriptive statistics. They will be compared with the standard armTimepoint: Clinical and radiological response rates at the first follow-up (6 weeks) would be reported as descriptive statistics. They will be compared with the standard arm | — |
Secondary
| Measure | Time frame |
|---|---|
| . Interventions in the form of surgery or Palliative chemotherapy 2. Any deaths 3. Delay in completion of Scheduled treatment due to any cause. A delay of more than 1 week would be considered as Prolonged treatment.Timepoint: Through the follow up period | — |
Countries
India
Contacts
Public ContactDr Suparna Kanti Pal
Institute of Post Graduate Medical Education and Research Kolkata
Outcome results
None listed