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

Phase 3

• Conditions: Cervical Cancer
• Interventions: Radiation: Radiotherapy; Drug: paclitaxel; Drug: cisplatin

• Registration Number: NCT01756170
• Lead Sponsor: xie congying

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-25
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Radiotherapy	Patients receive radiotherapy alone as in arm 1.
Arm 1	cisplatin	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.
Arm 1	Radiotherapy	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.
Arm 1	paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China