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临床试验/NCT01628757
NCT01628757Unknown不适用

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

Ding Ma1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2012年6月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,400
试验地点
1
主要终点
The clinical and pathological response to neoadjuvant chemotherapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Untreated cervical cancer with FIGO stage Ib-IIIb
  • Measurable lesions
  • Possible to radical hysterectomy
  • Age: 18 and older
  • Karnofsky Performance Status≥
  • 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

排除标准

  • Previous history of cancer
  • Patients with previous treatment
  • Patients without information of clinical risk factors
  • Patients who have active infection

结局指标

主要结局

The clinical and pathological response to neoadjuvant chemotherapy

时间窗: 1 to 3 months

including: ① clinical response(tumor size), ②pathological response(\<3 mm or not), ③toxic response (degree) and so on.

次要结局

  • long-term response for patients undergoing neoadjuvant chemotherapy(up to 10 years to 20 years or more)

研究者

发起方
Ding Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ding Ma

Prof. of Dept. of O & G

Huazhong University of Science and Technology

研究点 (1)

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