Clinical trial NCT01755845: Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
Official title: Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: cervical cancer
radiotherapy
postoperative therapy
chemotherapy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

Detailed description: Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
* One or more risk factors (lymph node involvement, resection margin involvement, parametrial 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
* Metastasis to paraaortic lymph node

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References: