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

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ClinicalTrials.gov Identifier: NCT04121975
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Radiotherapy Drug: Endostar Drug: Cisplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Name: Recombinant human endostatin

Drug: Cisplatin
30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.




Primary Outcome Measures :
  1. progression-free survival (PFS) rate at 1 year [ Time Frame: 1 year ]
    The rates of patients who were progression free at 1-year after enrollment


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 year ]
    Progression-free survival (PFS) is defined as the time from enrollment to disease progression or death from any cause.

  2. Overall survival [ Time Frame: 2 year ]
    Overall survival was defined as the time from enrollment to death from any cause

  3. Treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
    Treatment-related adverse events



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121975


Contacts
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Contact: Hanmei Lou, PHD +86-13456856364 louhm@zjcc.org.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Hanmei Lou, PHD    +86-13456856364    louhm@zjcc.org.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Hanmei Lou, PHD Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04121975     History of Changes
Other Study ID Numbers: Endo-CC-01
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Endostar protein
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors