Cervical Cancer, Chemotherapy
Conditions
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.
Interventions
DRUGTegafur, Gimeracil and Oteracil Potassium Capsules (one drug)
CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3-year/5-year | The time from enrollment to disease progression or death from any cause, whichever is first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local regional recurrence-free survival | 3-year/5-year | The time from enrollment to local regional recurrence or death from any cause, whichever is first. |
| Acute toxicities | From the start of treatment to 3 months | Evaluated with CTCAE 5.0 |
| Late toxicities | 3-year/5-year | Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme |
| Distant metastasis-free survival | 3-year/5-year | The time from enrollment to distant metastasis or death from any cause, whichever is first. |
Contacts
Primary ContactKe Hu, MD
Outcome results
None listed