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

Primary Purpose

Cervical Cancer, Chemotherapy

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Consolidation therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival

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

Secondary Outcome Measures

Distant metastasis-free survival

The time from enrollment to distant metastasis or death from any cause, whichever is first.

Local regional recurrence-free survival

The time from enrollment to local regional recurrence or death from any cause, whichever is first.

Acute toxicities

Evaluated with CTCAE 5.0

Late toxicities

Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Full Information

NCT ID

NCT04310774

First Posted

March 13, 2020

Last Updated

March 17, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04310774

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 15, 2020 (Anticipated)

Primary Completion Date

April 15, 2024 (Anticipated)

Study Completion Date

April 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Consolidation therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)

Other Intervention Name(s)

CCRT followed by consolidation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

3-year/5-year

Secondary Outcome Measure Information:

Title

Distant metastasis-free survival

Description

The time from enrollment to distant metastasis or death from any cause, whichever is first.

Time Frame

3-year/5-year

Title

Local regional recurrence-free survival

Description

The time from enrollment to local regional recurrence or death from any cause, whichever is first.

Time Frame

3-year/5-year

Title

Acute toxicities

Description

Evaluated with CTCAE 5.0

Time Frame

From the start of treatment to 3 months

Title

Late toxicities

Description

Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Time Frame

3-year/5-year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ke Hu, MD

Phone

+86-01069155487

huk@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ke Hu, MD

Organizational Affiliation

Radiotherapy department, Peking Union Medical College Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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