a phase 3 study of chemotherapy folowed by surgery and postoperative chemotherapy compared to initial surgery followed by chemotherapy in advanced ovarian cancer

A randomized controlled trial of neoadjuvant chemotherapy with interval cytoreduction vs primary cytoreduction in advanced (stage IIIc/IV) epithelial ovarian cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004363

Enrollment

Registered

2014-01-28

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: null- epithelial cancer ovary

Interventions

Intervention1: cispaltin, paclitaxel: randomization Intervention2: cisplatin,paclitaxel: after surgery 6 cycles of chemotherapy Intervention3: neoadjuvant chemotherapy with interval cytoreduction: Pac

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previously untreated patients with cytologically/histologically proven ovarian cancer showing peritoneal deposits outside the pelvis of >2cms either clinically/ radiologically 2. Patients with cytological/histologically proven ovarian cancer with regional lymph node metastasis 3. Patients with malignant pleural effusion confirmed to be of ovarian origin,

Exclusion criteria

Exclusion criteria: 1. Patients with early stage ovarian cancer and those with peritoneal deposits 2. Patients with distant metastasis except mentioned above. 3. Nonepithelial tumors of ovary such as germ cell tumor, sexcord stromal tumor etc. 4. Patients who have been previously treated or started treatment outside the institute or recurrent lesions will be excluded. 5. Patients with poor performance status or medical contraindications for chemotherapy and/or surgery will be excluded

Design outcomes

Primary

Measure	Time frame
To compare primary debulking surgery followed by chemotherapy and neoadjuvant chemotherapy followed by interval debulking surgery and additional chemotherapy in women with stage IIIc/IV epithelial ovarian carcinoma. 2. To compare operating time, blood loss, organ resections needed, perioperative complications and length of postoperative stay in the two groups.Timepoint: February 2015	—

Secondary

Measure	Time frame
To compare the rates of optimal cytoreduction in both the groups 4. To compare loco-regional recurrence rates and disease free survival in the two groups. Timepoint: To compare the rates of optimal cytoreduction in both the groups 4. To compare loco-regional recurrence rates and disease free survival in the two groups.	—

Countries

India

Contacts

Public ContactNarendra H

Sri venkateswara institute of medical sciences

jayaprakash27.9@gmail.com919441450981

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026