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Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer

NCT03622827 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-14

No results posted yet for this study

Summary

To assess the efficacy and safety of postoperative concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in patients with high-risk early stage cervical cancer.

Conditions

  • Uterine Cervical Neoplasms

Interventions

COMBINATION_PRODUCT

Chemoradiotherapy+ Endostar

Chemoradiotherapy with Endostar： * Chemoradiotherapy: pelvic radiotherapy starts 2-3 weeks after surgery. Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy. The external beam radiotherapy should be completed within 6 weeks. * Concurrent chemotherapy is consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks. * Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks.

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • Ke Gu, M.D., Ph.D · The Affiliated Suzhou Hospital of Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2023-07-30
Completion
2025-07-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622827 on ClinicalTrials.gov