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

NCT04121975 | Unknown Phase 2

• 1 other identifier: Endo-CC-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS) rate at 1 year

  The rates of patients who were progression free at 1-year after enrollment

  1 year

Secondary Outcomes (3)

• Progression-free survival

  2 year

• Overall survival

  2 year

• Treatment-related adverse events as assessed by CTCAE v4.0

  1 year

Study Arms (1)

Chemoradiotherapy

EXPERIMENTAL

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; Drug: Endostar; Drug: Cisplatin

Interventions

Radiotherapy RADIATION

Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.

Chemoradiotherapy

Endostar DRUG

30 mg/d was administered on days 1-5 every two weeks for 4 cycles.

Also known as: Recombinant human endostatin

Chemoradiotherapy

Cisplatin DRUG

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

Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy; endostar protein; Endostatins; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hanmei Lou, PHD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanmei Lou, PHD

CONTACT

+86-13456856364; louhm@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

CN (1)