Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01628757
Recruitment Status : Recruiting
First Posted : June 27, 2012
Last Update Posted : May 17, 2016
Sponsor:
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
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Tracking Information
First Submitted Date June 26, 2012
First Posted Date June 27, 2012
Last Update Posted Date May 17, 2016
Study Start Date Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2016)
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.
Original Primary Outcome Measures
 (submitted: June 26, 2012)
The clinical and pathological response to neoadjuvant chemotherapy
Change History Complete list of historical versions of study NCT01628757 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 25, 2016)
long-term response for patients undergoing neoadjuvant chemotherapy [ Time Frame: up to 10 years to 20 years or more ]
including ① DFS, ②OS, ③long-term complications,④secondary diseases, ⑤life quality, ⑥long-term toxic effects caused by the treatment and so on.
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer
Official Title Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Samples with DNA from blood,TCT,pap smear,and hpv, as well as body fluid and tissues.
Sampling Method Probability Sample
Study Population Patients with histologically confirmed Ib~ IIIb cervical carcinoma underwent Neoadjuvant Chemotherapy
Condition Cervical Cancer
Intervention Not Provided
Study Groups/Cohorts neoadjuvant chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2016)
1400
Original Estimated Enrollment
 (submitted: June 26, 2012)
400
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous history of cancer
  • Patients with previous treatment
  • Patients without information of clinical risk factors
  • Patients who have active infection
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01628757
Other Study ID Numbers GM2011-07-01
CERVca02/2002 ( Other Identifier: HUST, ZJU, SDU,Sun Yat-sen University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ding Ma, Huazhong University of Science and Technology
Study Sponsor Ding Ma
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
Investigators Not Provided
PRS Account Huazhong University of Science and Technology
Verification Date May 2016