Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients

NCT ID: NCT01756170

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 2

Patients receive radiotherapy alone as in arm 1.

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: RADIATION

Arm 1

Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area.

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Interventions

paclitaxel

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

xie congying

OTHER

Sponsor Role: lead

Responsible Party

xie congying

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Congying Xie, MD

Role: STUDY_DIRECTOR

the 1st Affiliated Hospital of Wenzhou Medical College

Locations

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

congying xie, MD

Role: CONTACT

wzxiecongying@163.com

+86-577-88069316

Facility Contacts

congying xie, MD

Role: primary

wzxiecongying@163.com

+86-577-88069316

Other Identifiers

WZMC-11352

Identifier Type: -

Identifier Source: org_study_id