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

NCT04310774 | Not Yet Recruiting Phase 1

• 1 other identifier: PUMCH-S1
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time from enrollment to disease progression or death from any cause, whichever is first

  3-year/5-year

Secondary Outcomes (4)

• Distant metastasis-free survival

  3-year/5-year

• Local regional recurrence-free survival

  3-year/5-year

• Acute toxicities

  From the start of treatment to 3 months

• Late toxicities

  3-year/5-year

Study Arms (1)

Consolidation therapy

EXPERIMENTAL

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

Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)

Interventions

Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug) DRUG

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

Also known as: CCRT followed by consolidation therapy

Consolidation therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Tegafur; gimeracil; potassium oxonate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ke Hu, MD

  Radiotherapy department, Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Ke Hu, MD

CONTACT

+86-01069155487; huk@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: April 15, 2020
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2026
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share