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

Phase 3

Recruiting

Conditions: epithelial cancer ovary

Registration Number: CTRI/2014/01/004363

Lead Sponsor: Sri Venkateswara Institute of Medical Sciences

Brief Summary: Ovarian cancer is the second most common gynceological malignancy world wide. In India it is the third most common cancer among women. Most of the women present at an advanced stage leading to higher morbidity and moratality. The current standard treatment to advanced epitehlial ovarian cancer is primary surgery followed by 6 cycles of platinum based adjuvant chemotherapy. There is no level 1 evidence to this approach. An alternate has been recently proposed and tested by some authors. This included initial 3 cycles of platinum based chemotherapy followed by surgery and later additional 3 cycles of chemotherapy. In this study we are comparing these two approaches in a randomized manner.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 60

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

1.Patients with early stage ovarian cancer and those with peritoneal deposits <2 cms.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. To compare operating time, blood loss, organ resections needed, perioperative complications and length of postoperative stay in the two groups.	February 2015
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.	February 2015

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Department of surgical oncology, Sri Venkateswara Institute of Medical Sciences
🇮🇳
Chittoor, ANDHRA PRADESH, India
Department of surgical oncology, Sri Venkateswara Institute of Medical Sciences
🇮🇳Chittoor, ANDHRA PRADESH, India
Dr Narendra H
Principal investigator
7382629699
drnarendrah@yahoo.co.in