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Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in treating patients with locally advanced cervical cancer

A phase II study of anti-angiogenesis inhibitor combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locally advanced cervical cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040892
Enrollment
Unknown
Registered
2020-12-14
Start date
2017-01-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

CCRT:Cisplatin: 40 mg/m2 for 5 weeks
IMRT: PTV1 50-54 Gy
PTV2 45-48.6 Gy
PTV3 45-48.6 Gy
HDR brachtherapy: 24 Gy in 4 fractions
CCRT+E:Endostar 7.5 mg/m2/d from D1 to D14 for 2 cycles, starting on the first day of IMRT
Cisplatin: 40 mg/m2/w for 5 weeks

Sponsors

People's Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Ages between 18-70 years; 2. Histologically proven and newly diagnosed cervical squamous carcinoma or adenocarcinoma; 3. Sstages between IB2-IVA according to the FIGO Staging System (version 2014); 4. Performance status (PS) score 0-1; 5. Measurable lesion; no distant metastases confirmed by abdominal ultrasound, chest computed tomography (CT), and bone emission computed tomography (ECT); 6. Life expectancy >= 6 months; 7. Signed study-specific consent form; 8. White blood cell count >= 4.0 x 10^9 /L, platelet count >= 100 x 10^9 /L; 9. Normal prothrombin time; 10. Values of liver and renal functions <= 1.25 x upper normal limits; 11. Able to meet follow-up requirement.

Exclusion criteria

Exclusion criteria: 1. Distant metastases upon diagnosis; 2. Coexistence of other malignance; 3. Prior treatment with anti-tumor therapies, including RT, chemotherapy, and targeted therapy; 4. Contraindication to RT or chemotherapy, including severe infection, myocardial infarct, severe arrhythmia, severe cerebrovascular disease, mental disorder, and uncontrolled diabetes; 5. Lactating women; 6. Currently treated with other targeted therapy; 7. Patients currently in other clinical trials.

Design outcomes

Primary

MeasureTime frame
PFS;Acute toxicity;

Secondary

MeasureTime frame
OS;DMFS;LRRFS;

Countries

China

Contacts

Public ContactHeming Lu

People's Hospital of Guangxi Zhuang Autonomous Region

luhming3632@163.com+86 771-218-6504

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026