CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer

Study Overview
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Brief Summary
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This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer.

Detailed Description
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This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer. The main inclusive criteria are as follows: histology confirmed cervical cancer; 18-70 years old; 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIC2; ECOG score <=1 point. The estimated enrollment is 200 patients. After enrollment, patients will receive CCRT, including external beam radiotherapy, intracavitary brachytherapy and concurrent chemotherapy. One month after the completion of CCRT, patients will receive 6 cycles of Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy. The primary endpoint is progression free survival. And the secondary endpoints include overall survival, distant metastasis-free survival, local regional recurrence-free survival, acute toxicities, late toxicities, and treatment compliance.

Official Title
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Concurrent Chemoradiotherapy Followed by Tegafur, Gimeracil and Oteracil Potassium Consolidation Chemotherapy in Patients With Locally Advanced Cervical Cancer: a Single Institute, Prospective, Single-arm Trial

Conditions
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Cervical Cancer, Chemotherapy

Intervention / Treatment
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* Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histology confirmed cervical cancer; 18-70 years old; 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIC2; Eastern Cooperative Oncology Group (ECOG) score <=1 point.; Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L; Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN). Exclusion Criteria: Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes; Prior malignancy;History of previous radiotherapy to the abdomen or pelvis; Pregnancy or lactation; Active infection with fever; Ssevere disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consolidation therapy<br>CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy | Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)<br>* CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy<br>* Other names: CCRT followed by consolidation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The time from enrollment to disease progression or death from any cause, whichever is first | 3-year/5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant metastasis-free survival | The time from enrollment to distant metastasis or death from any cause, whichever is first. | 3-year/5-year | 
| Local regional recurrence-free survival | The time from enrollment to local regional recurrence or death from any cause, whichever is first. | 3-year/5-year | 
| Acute toxicities | Evaluated with CTCAE 5.0 | From the start of treatment to 3 months | 
| Late toxicities | Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme | 3-year/5-year |