Status:
NOT_YET_RECRUITING
CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Cervical Cancer
Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04310774
Start Date
April 15 2020
End Date
April 15 2026
Last Update
March 19 2020
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