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

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Status and phase: Unknown; Phase 3

Conditions: Cervical Cancer

Treatments: Radiation: Radiotherapy; Drug: paclitaxel; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01756170

WZMC-11352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Arm 2

Active Comparator group

Description:

Patients receive radiotherapy alone as in arm 1.

Treatment:

Radiation: Radiotherapy

Arm 1

Experimental group

Description:

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.

Treatment:

Radiation: Radiotherapy

Drug: paclitaxel

Drug: cisplatin