Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-26 @ 8:09 PM
Study NCT ID:
NCT02492503
Status:
UNKNOWN
Last Update Posted:
2015-07-08
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
Sponsor:
All India Institute of Medical Sciences
Organization:
Study Overview
Official Title:
An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.
Detailed Description:
This trial will be a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at IRCH, AIIMS will be taken into study after taking informed consent. Patients will be randomized into two arms. Each arm shall contain 20 patients. The patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: