Cervical CancerNCT01628757
Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer
An observational study of Cervical Cancer, run by Ding Ma at 1 site in China.
Trial summary
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Dec 2023
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed Ib~ IIIb cervical carcinoma underwent Neoadjuvant Chemotherapy
Who may be able to join
- Untreated cervical cancer with FIGO stage Ib-IIIb
- Measurable lesions
- Possible to radical hysterectomy
- Age: 18 and older
- Karnofsky Performance Status≥ 70.
- WBC > 3,000/mm³, Hb > 9.0g/dl, Platelet > 100,000 /mm³, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG
- Written informed consent
Who cannot join
- Previous history of cancer
- Patients with previous treatment
- Patients without information of clinical risk factors
- Patients who have active infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Ma Ding, M.D., 86-27-8362681, dma@tjh.tjmu.edu.cn
About this study
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.
However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.
This study is undertaken to build a model combine both clinical and genetic factors to predict the effects of neoadjuvant chemotherapy.
Read the detailed description
Cervical cancer has been one of the most commom malignant diseases among femails, and do a lot of harm to both young and older women, especially to the people in the undeveloped areas. Neoadjuvant chemotherapy has been investigated for treatment of cervical cancer patients since 1980s around the world(Sardi J, Di Paola G, Giaroli A, Sananes C, Burlando S and Rueda NG,1988;Mancuso S, Benedetti Panici P, Greggi S and Scambia G,1989.). Clinicians found that neoadjuvant chemotherapy can help to diminish the tumor size,eliminate the distant metastasis; thus, patients can get the opportunity of surgery (Benedetti Panici P, Scambia G, Greggi S, Di Roberto P, Baiocchi G and Mancuso S,1988). As a result, women may have the chance to have their ovarian function preserved; and by plus surgery and post-surgery therapy, the women may also be able to be cured in the areas where sophisticated radiotherapy utilities are not availble.
As the development of science and techonology in chemotherapy for cervical cancer, the neoadjuvant therapy was also brought into China. And since 1990s, the investigation of neoadjuvant chemotherapy in China has been carried out in the teaching hospitals of China's leading famous universities in the developed aress. Strengthened by the prosperous economy of the countries, neoadjuvant chemotherapy began familar to China's Gyneclogists before the ending of the 20th century.
Since the beginning of the 21th century, that's in the early 2000s, neoadjuvant chemotherapy has been introduced as a new therapeutic therapy method. Neoadjuvant chemotherapy has also showed its own advantages (Chang TC, Lai CH, Hong JH, Hsueh S, Huang KG, Chou HH, Tseng CJ, Tsai CS, Chang JT, Lin CT, Chang HH, Chao PJ, Ng KK, Tang SG and Soong YK, 2000) and carried out in our hospitals, with the approvements of the institutions. Response both short-term and long-term response were evaluated. Clinical response, which is also known as early reponse, is also one of the short-term response, and has also been evaluated according to the response criterion. Patients' toxicity and long-term survival have also been recorded and evaluated. The treatment, as well as the study, was carried out in accordance with the approved guidelines. All eligible patients gave written informed consent before therapy. All protocols were approved by the ethical committees in the universities or the institutions, and updated with the renovated Declaration of Helsinki.
Since the middle stage or the late stage of 2000s, more clinicians have studied neoadjuvant chemotherapy in the top universities hospitals as well as our hospitals, and taken the chemotherapy regimens to the hospitals and institutions of theirs for the treatment of cervical cancer patients. Some of them have also taken part in the study with us.
And since the begining of the 2010s, more hospitals have taken part in the neoadjuvant study with us, and the number of the institutions have been updated with updation of protocols and ethical approvements. Patients who have fulfilled the inclusion criterion have been included with exclusion of disabled patients, such as Karnofsky Performance Status < 70,hepatic dysfunction, cardiac dysfunction and so on.
Although Concurrent Chemoradiotherapy has been treated as an standard treatment of cervical cancer (ref 4-6), neoadjuvant chemotherapy has also showed its own advantages (Chang TC, Lai CH, Hong JH, Hsueh S, Huang KG, Chou HH, Tseng CJ, Tsai CS, Chang JT, Lin CT, Chang HH, Chao PJ, Ng KK, Tang SG and Soong YK, 2000): it can facilitate premenopause women to have their ovarian function preserved in addition to the facility of radical surgery, some people have so good response that the tumor disappear completely after neosdjuvant chemotherapy. This may open an new window to young women who want to have their fertility (including uterus and ovaries) preserved. And the mechanism of chemotherapy-response and chemo-resistence in still need to be widely and deeply explored, which is also important for clinicians to understand the pathway of chemo-drugs' metablism and to avoid the toxic effect of the chemo-drugs.
- Conditions
- Cervical Cancer
- 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 |
|---|---|---|
| neoadjuvant chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical and pathological response to neoadjuvant chemotherapy
including: ① clinical response(tumor size), ②pathological response(<3 mm or not), ③toxic response (degree) and so on.
Measured: 1 to 3 months
Secondary outcomes (1)
long-term response for patients undergoing neoadjuvant chemotherapy
including ① DFS, ②OS, ③long-term complications,④secondary diseases, ⑤life quality, ⑥long-term toxic effects caused by the treatment and so on.
Measured: up to 10 years to 20 years or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ding Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Shandong University, Sun Yat-sen University, Wuhan University, Hubei Women and Children's Hospital, Wuhan General Hospital of Guangzhou Military Command, Xiangfan Central Hospital, Wuhan Central Hospital, Hubei University for nationalities
- Responsible party
- Sponsor-investigator, Ding Ma, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628757
- Sponsor's protocol ID
- GM2011-07-01
- Other IDs
- CERVca02/2002
- Status last verified
- May 2016
- First submitted
- 26 Jun 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer
- ClinicalTrials.gov ID
- NCT01628757
- Acronym / sponsor ID
- GM2011-07-01
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Ding MaUniversity, hospital or other
- Collaborators
- Zhejiang University, Shandong University, Sun Yat-sen University, Wuhan University, Hubei Women and Children's Hospital, Wuhan General Hospital of Guangzhou Military Command, Xiangfan Central Hospital, Wuhan Central Hospital, Hubei University for nationalities
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jun 2012 (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.
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.
However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.
This study is undertaken to build a model combine both clinical and genetic factors to predict the effects of neoadjuvant chemotherapy.
Detailed description
Cervical cancer has been one of the most commom malignant diseases among femails, and do a lot of harm to both young and older women, especially to the people in the undeveloped areas. Neoadjuvant chemotherapy has been investigated for treatment of cervical cancer patients since 1980s around the world(Sardi J, Di Paola G, Giaroli A, Sananes C, Burlando S and Rueda NG,1988;Mancuso S, Benedetti Panici P, Greggi S and Scambia G,1989.). Clinicians found that neoadjuvant chemotherapy can help to diminish the tumor size,eliminate the distant metastasis; thus, patients can get the opportunity of surgery (Benedetti Panici P, Scambia G, Greggi S, Di Roberto P, Baiocchi G and Mancuso S,1988). As a result, women may have the chance to have their ovarian function preserved; and by plus surgery and post-surgery therapy, the women may also be able to be cured in the areas where sophisticated radiotherapy utilities are not availble.
As the development of science and techonology in chemotherapy for cervical cancer, the neoadjuvant therapy was also brought into China. And since 1990s, the investigation of neoadjuvant chemotherapy in China has been carried out in the teaching hospitals of China's leading famous universities in the developed aress. Strengthened by the prosperous economy of the countries, neoadjuvant chemotherapy began familar to China's Gyneclogists before the ending of the 20th century.
Since the beginning of the 21th century, that's in the early 2000s, neoadjuvant chemotherapy has been introduced as a new therapeutic therapy method. Neoadjuvant chemotherapy has also showed its own advantages (Chang TC, Lai CH, Hong JH, Hsueh S, Huang KG, Chou HH, Tseng CJ, Tsai CS, Chang JT, Lin CT, Chang HH, Chao PJ, Ng KK, Tang SG and Soong YK, 2000) and carried out in our hospitals, with the approvements of the institutions. Response both short-term and long-term response were evaluated. Clinical response, which is also known as early reponse, is also one of the short-term response, and has also been evaluated according to the response criterion. Patients' toxicity and long-term survival have also been recorded and evaluated. The treatment, as well as the study, was carried out in accordance with the approved guidelines. All eligible patients gave written informed consent before therapy. All protocols were approved by the ethical committees in the universities or the institutions, and updated with the renovated Declaration of Helsinki.
Since the middle stage or the late stage of 2000s, more clinicians have studied neoadjuvant chemotherapy in the top universities hospitals as well as our hospitals, and taken the chemotherapy regimens to the hospitals and institutions of theirs for the treatment of cervical cancer patients. Some of them have also taken part in the study with us.
And since the begining of the 2010s, more hospitals have taken part in the neoadjuvant study with us, and the number of the institutions have been updated with updation of protocols and ethical approvements. Patients who have fulfilled the inclusion criterion have been included with exclusion of disabled patients, such as Karnofsky Performance Status < 70,hepatic dysfunction, cardiac dysfunction and so on.
Although Concurrent Chemoradiotherapy has been treated as an standard treatment of cervical cancer (ref 4-6), neoadjuvant chemotherapy has also showed its own advantages (Chang TC, Lai CH, Hong JH, Hsueh S, Huang KG, Chou HH, Tseng CJ, Tsai CS, Chang JT, Lin CT, Chang HH, Chao PJ, Ng KK, Tang SG and Soong YK, 2000): it can facilitate premenopause women to have their ovarian function preserved in addition to the facility of radical surgery, some people have so good response that the tumor disappear completely after neosdjuvant chemotherapy. This may open an new window to young women who want to have their fertility (including uterus and ovaries) preserved. And the mechanism of chemotherapy-response and chemo-resistence in still need to be widely and deeply explored, which is also important for clinicians to understand the pathway of chemo-drugs' metablism and to avoid the toxic effect of the chemo-drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed Ib~ IIIb cervical carcinoma underwent Neoadjuvant Chemotherapy
Key inclusion criteria (7 listed)
- Untreated cervical cancer with FIGO stage Ib-IIIb
- Measurable lesions
- Possible to radical hysterectomy
- Age: 18 and older
- Karnofsky Performance Status≥ 70.
Key exclusion criteria (4 listed)
- Previous history of cancer
- Patients with previous treatment
- Patients without information of clinical risk factors
- Patients who have active infection
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
The clinical and pathological response to neoadjuvant chemotherapy
Time frame: 1 to 3 months
including: ① clinical response(tumor size), ②pathological response(<3 mm or not), ③toxic response (degree) and so on.
1 secondary outcome
long-term response for patients undergoing neoadjuvant chemotherapy
Time frame: up to 10 years to 20 years or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
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 Ding Ma 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 7 inclusion and 4 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 17 May 2016. 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 Ma Ding, M.D. (86-27-8362681, dma@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical and pathological response to neoadjuvant chemotherapy (time frame: 1 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2016.