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A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. Patients were randomly divided into two groups, with 60 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locally advanced cervical carcinoma with high efficacy and low toxicity.
This study was a multicenter, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. These patients were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 45-50Gy, DDP 40mg/m2, per week for 5cycles, Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles) and concurrent chemoradiotherapy group ( IMRT 45-50Gy, DDP 40mg/m2, per week, for 5cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| concurrent chemoradiotherapy + endostar | Experimental | 4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy |
|
| concurrent chemoradiotherapy | Active Comparator | 5 cycles of DDP concurrent with radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug | Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| short-time effect | 3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS was calculated from the date of entry into the study to the date of death or the last follow-up visit. | 3 years,5 years |
| Progression-Free Survival | PFS was calculated from the date of entry into the study to the date of first physical or radio-graphic evidence of disease progression, death or the last follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Zhang, MD | First Affiliated Hospital of Guangxi Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41049580 | Derived | Wu F, Tang X, Liu W, Luo Z, Huang H, Liu M, Wang H, Liao S, Ma S, Jiang L, Zhang Y. Efficacy of Endostar plus concurrent chemoradiotherapy in locally advanced cervical cancer: a multicenter, phase II randomized trial. Ther Adv Med Oncol. 2025 Oct 3;17:17588359251379397. doi: 10.1177/17588359251379397. eCollection 2025. |
| Label | URL |
|---|---|
| Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D043169 | Endostatins |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| DDP | Drug | DDP: 40mg /m2,per week, for 5 cycles |
|
|
| 3 years,5 years |
| Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa | View source |
| Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 2000;18:1 | View source |
| Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 1999;340:1137-1143. | View source |
| Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. | View source |
| Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. | View source |
| Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer | View source |
| A randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stages IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes | View source |
| Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis | View source |
| Clinical efficacy of modified preoperative neoadjuvant chemotherapy in the treatment of locally advanced (stage IB2 to IIB) cervical cancer: randomized study | View source |
| Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials | View source |
| Modern radiotherapy and cervical cancer. | View source |
| Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study | View source |
| A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer | View source |
| Role of angiogenesis in tumor growth and metastasis | View source |
| Antiangiogenic agents and their promising potential in combined therapy | View source |
| Function of endogenous inhibitors of angiogenesis as endothelium specific tumor suppressors | View source |
| Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung caner | View source |
| Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cerix: a gynecologic oncology group study | View source |
| Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: a phase III randomized trial of the Gynecologic Oncology Group | View source |
| Clinical potential of bevacizumab in the treatment of metastatic and locally advanced cervical cancer | View source |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |