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

NCT ID: NCT04310774

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2026-04-15

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 consolidation chemotherapy in patients with locally advanced cervical cancer.

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 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.

Conditions

Cervical Cancer; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Consolidation therapy

CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy

Group Type: EXPERIMENTAL

Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)

Intervention Type: DRUG

CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy

Interventions

Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)

CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy

Intervention Type: DRUG

Other Intervention Names

CCRT followed by consolidation therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ke Hu, MD

Role: STUDY_CHAIR

Radiotherapy department, Peking Union Medical College Hospital

Central Contacts

Ke Hu, MD

Role: CONTACT

huk@pumch.cn

+86-01069155487

Other Identifiers

PUMCH-S1

Identifier Type: -

Identifier Source: org_study_id