The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Study Overview
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Brief Summary
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The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Detailed Description
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Objective: To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT. Patients: Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin） MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). Methods: The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Official Title
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Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: CCRT
* Drug: Paclitaxel, Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). ECOG<2 Expected survival is longer than six months Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial Exclusion Criteria: Activity or uncontrol severe infection Liver cirrhosis, Decompensated liver disease History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure Have suffered or combined with other malignant tumor Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure A history targeted therapy or pelvic artery embolization Artery-enous thrombosis within 6 months Patients with autoimmune diseases Complications, need to be treatment with drugs which may lead to liver or kidney injury Patients with disease progression after chemoradiation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: control group<br>In this group, observation is given after CCRT. | Radiation: CCRT<br>* Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)<br>* Other names: control group: CCRT + observation;|
| Experimental: trial group<br>In this group, adjuvant chemotherapy is given after CCRT. | Radiation: CCRT<br>* Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)<br>* Other names: control group: CCRT + observation;Drug: Paclitaxel, Cisplatin<br>* The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.<br>* Other names: trial group: CCRT + adjuvant chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | 5 years overall survival | 5 years | 
| ORR | To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally adcanced, CCRT, Adjuvant chemotherapy