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Clinical trial for ovarian cancer in India

Primary versus interval CRS for patients with advanced (Stage IIIC and IVA) serous epithelial ovarian, fallopian tube and primary peritoneal cancer â?? a prospective non-randomized multi-centric study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/08/015350
Enrollment
200
Registered
2018-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Health Condition 2: C569- Malignant neoplasm of unspecifiedovary

Interventions

None listed

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with stages III C and IV A (new FIGO classification) serous epithelial ovarian, fallopian tube and primary peritoneal cancer 2. Age between 18-75 years 3. ECOG performance status of >2, ASA 1 or 2 4. Histologically/cytologically proven ovarian, fallopian tube or primary peritoneal carcinoma 5. In case the diagnosis is made on cytology, mullerian origin is confirmed by immunohistochemistry or other primary sites are ruled out by appropriate investigations (colonoscopy, upper GI scopy, ratio of CA-125 to CEA >25.) 6. Laboratory values: serum creatinine 3.5 x 109/l; platelets > 100 x 109 /l

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS) and Overall survival (OS) Timepoint: 6 months 18 months 3 years 5 years

Secondary

MeasureTime frame
90-day morbidity and mortality Comparison of total and selective perionectomy Benefit of HIPEC in addition to complete cytoreductive surgeryTimepoint: 1. 30 days following surgery 2. 90 days following surgery 3. 6 months 4. 18 months 5. 3 years 6. 5 yearsa

Countries

India

Contacts

Public ContactDipal Patel

Zydus Hospital

aditimodi31@gmail.com09686447863

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026