Post-operative intraperitoneal chemotherapy in epithelial ovarian cancer

Phase 3

• Conditions: Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

• Registration Number: CTRI/2020/01/022955
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical education and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age >=18 years

2. Newly diagnosed stage III/IVa epithelial ovarian, fallopian tube, or peritoneal cancer who received neoadjuvant chemotherapy and completed interval cytoreductive surgery

3. Patient should have achieved an optimal cytoreduction status ( largest residue <1 cm) at the time of random allocation

4. Patient should be considered fit for random allocation after the surgical procedure is completed

5. In case the upfront diagnosis was based on cytology only, the following criteria needs to be satisfied for including the patients for the trial:

-Absence of any other known site of cancer

-A 125 >= 200

-CA 125/CEA ratio > 25

-If CA125/CEA is < 25, then there must be available (within 6 weeks of registration) negative colonoscopy and upper GI endoscopy

Omental cake or other metastasis > 2 cm in upper abdomen and / or regional LN metastasis by CT/MRI or Ultrasound or laparoscopy

6. Primary chemotherapy should have consisted of at least 3 courses and maximum 4 courses of paclitaxel and carboplatin in standard doses.

7. ECOG performance status of 0-2 at the time of enrolment in the study

8. Negative serum/urine pregnancy test in women of childbearing potential (WOCBP)

9. Patients must provide a written informed consent prior to proceeding for surgery for possible randomization.

10. Adequate blood counts and organ functions (unless due to chemotherapy) :

-Hemoglobin >=8g/dL

-WBC counts: 4000-11000/cmm

ï?· Platelet counts: >=100,000/cmm

-Total Bilirubin<= 1.5 x ULN

-AST (SGOT) <= 3 x ULN

-ALT (SGPT) <= 3 x ULN

-Serum creatinine <= 2 mg/dL or a measured creatinine clearance >= 40 mL/min according to Cockcroft-Gault formula

Exclusion Criteria

1. Serious inter-current illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction that would preclude safe administration of the standard treatment.

2. Human Immunodeficiency Virus (HIV) infection/and or Anti-retroviral therapy and or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).

3. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HbeAg and HBV DNA titers must be negative and patients would be continued on appropriate prophylaxis with antivirals throughout the duration of the study).

4. Pre-existing peripheral neuropathy of > grade 1

5. Patients known to have borderline ovarian cancer or low grade ovarian cancer

6. Patients who have undergone partial therapy elsewhere will be excluded

7. Any intraoperative complications which would render the patient unfit for receiving intraperitoneal chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified