Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Study Overview
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Brief Summary
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The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

Detailed Description
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To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

Official Title
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Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer

Conditions
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Cervical Cancer, Toxicity Due to Radiotherapy

Intervention / Treatment
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* Radiation: Radiation
* Drug: cisplatin（DDP） weekly
* Drug: docetaxel plus cisplatin
* Drug: docetaxel plus cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years to 70 Years Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy Accepted radical hysterectomy 3-4 weeks before Karnofsky score >70 Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included. Examination results showed no radiation or chemotherapy contraindication Willing to accept treatment Ability to comply with trial requirements Exclusion Criteria: Postoperative residual Postoperative recurrence or metastasis Without lymph node dissection Postoperative pathology showed aortic lymph node metastasis Examination results showed radiotherapy contraindications No indications for radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCRT with cisplatin(DDP) weekly<br>concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation | Radiation: Radiation<br>* Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.<br>Drug: cisplatin（DDP） weekly<br>* concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation<br>|
| Experimental: CCRT with TP<br>concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation | Radiation: Radiation<br>* Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.<br>Drug: docetaxel plus cisplatin<br>* concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation<br>|
| Experimental: concurrent and adjuvant TP<br>2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation | Radiation: Radiation<br>* Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.<br>Drug: docetaxel plus cisplatin<br>* concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation<br>Drug: docetaxel plus cisplatin<br>* adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 years | 
| acute adverse events |  | 3 months | 
| chronic adverse events |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, postoperative risk factor, treatment