TORPEDO- clinical study for ovarian cancer

Not Applicable

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

• Registration Number: CTRI/2018/12/016789
• Lead Sponsor: o sponsor

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All patients with stages III C (new FIGO classification) serous epithelial ovarian, fallopian tube and primary peritoneal cancer

1. Age between 18-75 years•

ECOG performance status of >2, ASA 1 or 2

2. in case of pleural effusion cytology should be negative for tumour cells â?¨

3. Histologically/cytologically proven epithelial serous ovarian, fallopian tube or primary peritoneal carcinoma

4. In case diagnosis is made based on cytology only

Normal mammogram ( < 6 weeks before first registration) andâ?¨presence of pelvic mass andâ?¨CA 125 > 200 kU/l and Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digestive tract ( < 6 weeks before registration) and

Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)

5. Laboratory values: serum creatinine < 140 µmol/L; white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l

Exclusion Criteria

1.Patient refusing to consent

2.Patients with non-serous histologies like endometroid adenocarcinoma, mucinous carcinoma, clear cell carcinoma and other rare histologies

3.Patients with distant organ metastases like liver and lung metastases

4.Patients who do not undergo both surgery and chemotherapy

5.Patients who develop disease progression on chemotherapy (evaluated according to the RECIST criteria)

6.History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

7. Patients with active infection or other concurrent medical condition that could interfere in the ability of â?¨patients to receive the proposed treatment according to protocol; â?¨

8. Patients with performance status (ECOG) >2; â?¨

9. Patients with complete bowel obstruction; â?¨

10.Abnormal bone marrow indices or renal and liver function; â?¨

ASA IV or V. â?¨

Study & Design

• Study Type: Interventional
• Study Design: Not specified