Cervical CancerNCT01418859
Clinical Study in Post-operation Treatment of Cervical Cancer
An observational study of Cervical Cancer, run by Xi'an Jiaotong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, 710061
Zi Liu, M.D, 086-18991232167, 18991232167@189.cn
Tao Wang, M.D, 086-18991232386, 18991232386@189.cn
About this study
Official title: Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer
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).
Read the detailed description
Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, postoperation, chemotherapy, radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zi, Xi'an Jiaotong University
- Investigators
- Chen M W, M.D, Study director, Affiliated Hospital of Medical College of Xo'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418859
- Sponsor's protocol ID
- GCR-01
- Status last verified
- Mar 2012
- First submitted
- 16 Aug 2011
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25935645
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer
- ClinicalTrials.gov ID
- NCT01418859
- Acronym / sponsor ID
- GCR-01
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, postoperation, chemotherapy, radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Derived from this study: PubMed 25935645Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen M W, M.D study director
Affiliated Hospital of Medical College of Xo'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Zi, M.D (86-18991232167, liuzmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.