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CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Endostar
Cisplatin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from 18 to 65 years old;
  2. Histologically confirmed to be cervical squamous cell carcinoma;
  3. Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
  4. The ECOG PS score is 0 or 1;
  5. At least one measurable (measured according to RECIST 1.1);
  6. No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;
  7. This treatment must be the first course of treatment;
  8. The expected survival expectation is not less than 6 months;
  9. The main organ function meets the following criteria within 7 days before treatment:

Blood routine examination standard (without blood transfusion within 14 days):

  1. hemoglobin (HB) ≥ 90g / L;
  2. neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L;
  3. platelets (PLT) ≥ 80 × 10 9 / L.

Biochemical tests are subject to the following criteria:

  1. total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  2. alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN;
  3. serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance (CCr) ≥ 60ml / min;

Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).

(10) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment And must be non-lactating patients; (11) Can understand the study and have signed an informed consent form;

Exclusion Criteria:

  1. Patients with distant metastases;
  2. Those suffering from other malignant tumors;
  3. Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
  4. Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
  5. During pregnancy or lactation;
  6. Those who have received targeted therapy;
  7. Those who are in other drug trials;
  8. Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
  9. It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiotherapy

Arm Description

Radiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Outcomes

Primary Outcome Measures

progression-free survival (PFS) rate at 1 year
The rates of patients who were progression free at 1-year after enrollment

Secondary Outcome Measures

Progression-free survival
Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.
Overall survival
Overall survival was defined as the time from enrollment to death from any cause
Treatment-related adverse events as assessed by CTCAE v4.0
Treatment-related adverse events

Full Information

First Posted
October 9, 2019
Last Updated
October 9, 2019
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04121975
Brief Title
CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer
Official Title
Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
Detailed Description
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy
Arm Type
Experimental
Arm Description
Radiation: Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles. Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
Recombinant human endostatin
Intervention Description
30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
Primary Outcome Measure Information:
Title
progression-free survival (PFS) rate at 1 year
Description
The rates of patients who were progression free at 1-year after enrollment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.
Time Frame
2 year
Title
Overall survival
Description
Overall survival was defined as the time from enrollment to death from any cause
Time Frame
2 year
Title
Treatment-related adverse events as assessed by CTCAE v4.0
Description
Treatment-related adverse events
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 65 years old; Histologically confirmed to be cervical squamous cell carcinoma; Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage); The ECOG PS score is 0 or 1; At least one measurable (measured according to RECIST 1.1); No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc; This treatment must be the first course of treatment; The expected survival expectation is not less than 6 months; The main organ function meets the following criteria within 7 days before treatment: Blood routine examination standard (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g / L; neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L; platelets (PLT) ≥ 80 × 10 9 / L. Biochemical tests are subject to the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN; serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance (CCr) ≥ 60ml / min; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%). (10) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment And must be non-lactating patients; (11) Can understand the study and have signed an informed consent form; Exclusion Criteria: Patients with distant metastases; Those suffering from other malignant tumors; Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment; Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes; During pregnancy or lactation; Those who have received targeted therapy; Those who are in other drug trials; Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension; It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanmei Lou, PHD
Phone
+86-13456856364
Email
louhm@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanmei Lou, PHD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmei Lou, PHD
Phone
+86-13456856364
Email
louhm@zjcc.org.cn

12. IPD Sharing Statement

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CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer

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