Clinical Study in Post-operation Treatment of Cervical Cancer
Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer
1 other identifier
observational
183
1 country
1
Brief Summary
The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 21, 2012
March 1, 2012
1.3 years
August 16, 2011
March 19, 2012
Conditions
Keywords
Study Arms (3)
radiation therapy only
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive radiation therapy only. radiation therapy regimen: 3D-CRT pelvic radiation, 95%CTV DT 45Gy/25f. Radiation field include tumor bed and regional lymph nodes area. Upper border: branching of abdominal aorta. The radiation fields go down along the iliac vessels (including regions of 7mm out of the iliac vessels) and include the tumor bed region. Lower border: the inferior margin of obturator foramen.
concurrent chemoradiotherapy
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy. radiation therapy regimen is the same with radiation therapy only group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy.
concurrent and additional chemotherapy
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy, and additional chemotherapy after concurrent treatment. radiation therapy regimen is the same with radiation therapy group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy. Additional chemotherapy regimen is the same with concurrent chemotherapy, and will be carry out in the 4th and 8th week after radiation therapy.
Eligibility Criteria
patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion.
You may qualify if:
- patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
- squamous carcinoma;
- age\<70;
- Gynecologic Oncology Group (GOG):0-2.
You may not qualify if:
- negative nodes,surgical margin,and/or parametrium;
- No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, 710061, China
Related Publications (1)
Sun W, Wang T, Shi F, Wang J, Wang J, Hui B, Zhang Y, Lu J, Chen H, Liu Z. Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy. BMC Cancer. 2015 May 4;15:353. doi: 10.1186/s12885-015-1355-1.
PMID: 25935645DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chen M W, M.D
Affiliated Hospital of Medical College of Xo'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profesor
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 17, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2015
Last Updated
March 21, 2012
Record last verified: 2012-03