Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical cancer, radiotherapy, postoperative therapy, chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: paclitaxel Type: Drug
Name: cisplatin Type: Drug
Name: Radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.
Detailed Description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)

- Negative lymph node

- At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement)

- Eastern Cooperative Oncology Group 0-2

- Expected life span over 6 months.

- No distant metastasis

- Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)

- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

- Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)

- Written informed consent

Exclusion Criteria:

- Previous history of chemotherapy or radiation

- Hypersensitive reaction to platinum/paclitaxel agent

- History of other cancer

- Concurrent systemic illness not appropriate for chemotherapy

- Active infection requiring antibiotics

- Pregnancy
Location
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Status: Recruiting
Contact: congying xie, MD - +86-577-88069316 - wzxiecongying@163.com
Start Date
January 2011
Completion Date
December 2016
Sponsors
xie congying
Source
Wenzhou Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page