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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04310774
• Other study ID #: PUMCH-S1
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 15, 2020
• Est. completion date: April 15, 2026

Study information

• Verified date: March 2020
• Source: Peking Union Medical College Hospital
• Contact: Ke Hu, MD
• Phone: +86-01069155487
• Email: huk[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Chemotherapy
• Uterine Cervical Neoplasms

Intervention

Drug:
• Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)
CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The time from enrollment to disease progression or death from any cause, whichever is first	3-year/5-year
Secondary	Distant metastasis-free survival	The time from enrollment to distant metastasis or death from any cause, whichever is first.	3-year/5-year
Secondary	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
Secondary	Acute toxicities	Evaluated with CTCAE 5.0	From the start of treatment to 3 months
Secondary	Late toxicities	Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme	3-year/5-year