Trials / Unknown
UnknownNCT04310774
CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug) | CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy |
Timeline
- Start date
- 2020-04-15
- Primary completion
- 2024-04-15
- Completion
- 2026-04-15
- First posted
- 2020-03-17
- Last updated
- 2020-03-19
Source: ClinicalTrials.gov record NCT04310774. Inclusion in this directory is not an endorsement.