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

Symptoms and General Pathology

Hypoxia

Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)

Pelvic Irradiation with chemotherapy(cisplatin)

Only Pelvic Irradiation with chemotherapy(cisplatin)

Joo-young J Kim, M.D., Ph.D.

This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia marker) expression in the primary cervical tumor before randomization because it was expected that there would be a differential benefit of EFI in patients with CA9-positive vs CA9-negative tumors. However, the study design was modified because there was too much delay in the patient with CA9-negative tumors. The patients are now registered and then immediately randomized to experimental (EFI) and control arm (pelvis only treated) with examination of CA9 expression at later time.

Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix are included in this study. Absence of metastatic para-aortic lymphadenopathy is the prerequisite of the enrollment, and this is confirmed by imaging studies such as MRI covering the abdomen and pelvis, and PET/CT scan. The sample size is based on the previous studies (1-3). Considering that the disease-free survival of the experimental arm (patients who are treated with prophylactic para-aortic LN irradiation) and those who are not treated is 82% vs 72% (preliminary analysis), with the alpha error of 5% and statistical power of 90% (one-sided), a total of 140 patients in each treatment arm is needed. With 10% of follow-up loss taken into account, the total number of patients will be 312. Above figures were calculated on the basis of 80% statistical power and 5% type I error rate. PAN is treated prophylactically in the experimental arm with 45Gy/25F/5week fractionation schedule. Pelvis is treated according to the individual institute's practice guideline. Boost treatment for any enlarged pelvic lymph node or residual cervical/ parametrial disease with conformal radiation technique are allowed. Intracavitary radiation is given via low-dose-rate or high-dose-rate brachytherapy technique. Weekly cisplatin is given to all patients, however, when the patient's physical condition does not allow cisplatin administration, it can be omitted. This should be taken into account in the final analysis. The stage and the presence of pelvic lymphadenopathy are two stratification factors.

Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer

A Phase II Randomized Study of Prophylactic Irradiation of the Para-Aortic Lymph Nodes by 3-D Conformal Radiotherapy Technique With Concurrent Chemotherapy Based on the Hypoxic Status of Locally Advanced Uterine Cervical Cancer

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
Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer	NCT00980759	Cervical Cancer	EFI Pelvic RT	18 Years - 80 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for pelvic rt

Every month we try and update this database with for pelvic rt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pelvic rt

Every month we try and update this database with for pelvic rt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pelvic rt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.