Short versus long chemotherapy regiment for trophoblastic tumor
Phase 3
Completed
- Conditions
- Gestational trophoblastic neoplasia (GTN)Pregnancy and Childbirth
- Registration Number
- ISRCTN74959523
- Lead Sponsor
- ational Academy of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
1. Histologically proven post molar GTN (Persistent mole for =4 months) or choriocarcinoma
2. Female
3. Age 18 years or above
4. WHO risk score of 6 or less
5. Willing to practice effective contraception for the duration of the study
6. Consented for participation
Exclusion Criteria
1. Lactating
2. PSTT, non-gestational neoplasia
3. Abnormal CBC, LFT,RFT
4. Cancers in other organs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to achieve serum ß-hCG <5 mU/ml measured using the blood test at clinical laboratory of study site as a routine practice in the hospital prior to recruitment and then every 2 weeks before commencing each subsequent chemotherapy cycle until the level comes down to normal for two timepoints.
- Secondary Outcome Measures
Name Time Method 1. Total hospital admission days is measured using source document from treatment and discharge date.<br>2. Compliance to complete therapy is measured using defined follow up dates and rate of defaulter.<br>3. Need of high-risk regimen is measured by switch over into high-risk treatment regimen (if any).<br>4. Need of surgical intervention is measured using type of treatment received in each visit cycle.<br>