Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary.

Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.

radical hysterectomy + pelvic lymph node dissection

135-175 mg/m(2) intravenously (IV) on day 1

Pelvic RT

Ding Ma, MD, PhD

We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.

A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.

Zhejiang University

Shandong University

Huazhong University of Science and Technology

Director of Department of Gynecology and Obstetrics

This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.

Radical Hysterectomy + pelvic lymph node dissection

This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.

Simple hysterectomy + pelvic lymph node dissection

Marie Plante

Gwenael Ferron

Jae-Weon Kim

Christian Marth

John Tidy

Noreen Gleeson

Frederic Goffin

Cor de Kroon

Xiaohua Wu

Sven Mahner

Brynhildur Eyjolfsdottir

Alexey Shevchuk

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

At this time, it is not clear which of these approaches best balances the desire to prevent cancer of the cervix from returning with the risks of side effects after surgery and in the long-term.

Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE)

Pelvic relapse-free survival (PRFS), the primary endpoint of this study, is defined as the time from randomization to the time of documented evidence of recurrence within the pelvic field.

compare the two treatment arms with respect to:

* pelvic relapse-free survival
* Extra pelvic relapse-free survival
* Relapse-free survival (any site)
* Overall survival
* Treatment-related adverse events
* Patient Reported Outcomes including global quality of life and measures of sexual health
* Cost-effectiveness and cost-utility
* To observe the rates of the following in this patient population: sentinel node detection.
* Parametrial involvement
* Involvement of surgical margins
* Pelvic node involvement

Gynecologic Cancer Intergroup (GCIG)

Canadian Institutes of Health Research (CIHR)

Korean Gynecologic Oncology Group

Dutch Gynecologic Oncology Group

Cancer Trials Ireland

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

Belgium Gynecologic Oncology Group

Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

Institute of Cancer Research, United Kingdom

Shanghai Cancer Centre Deptartment of Gynecologic Oncology Fudan University

Hertzen Moscow Scientific Research Institute of Oncology

Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

Institut Claudius Regaud - Institute Universitaire du Cancer de Toulouse - Oncopole

Canadian Cancer Trials Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients	NCT01755897	Uterine Cervica... Cervical Cancer Uterine Cervica...	radical hystere... Paclitaxel Cisplatin Cisplatin Pelvic RT	- 65 Years	Huazhong University of Science and Technology
Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer	NCT01658930	Cervical Cancer	Radical Hystere... Simple hysterec...	18 Years -	Canadian Cancer Trials Group

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