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

Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Endostar; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hanmei Lou, PHD; Phone Number: +86-13456856364; Email: louhm@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Hanmei Lou, PHD; Phone Number: +86-13456856364; Email: louhm@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chemoradiotherapy; 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.	Radiation: Radiotherapy; 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.; Other Names: Recombinant human endostatin; Drug: Cisplatin; 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS) rate at 1 year	The rates of patients who were progression free at 1-year after enrollment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.	2 year
Overall survival	Overall survival was defined as the time from enrollment to death from any cause	2 year
Treatment-related adverse events as assessed by CTCAE v4.0	Treatment-related adverse events	1 year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Hanmei Lou, PHD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (ACTUAL): October 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Cisplatin; Endostar protein; Endostatins
• Other Study ID Numbers: Endo-CC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No