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Prophylactic Irradiation of the Para-Aortic Lymph Nodes and Supraclavicular Lymph Nodes in Locally Advanced Uterine Cervical Cancer

NCT01063387 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-02-05

No results posted yet for this study

Summary

This study is an open-label, randomized study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally advanced uterine cervical cancer. This study includes a translational research component in that all the primary tumors and lymph node are stained with Sema4c, before randomization. According to the investigators study result, patients with more pelvic lymph node metastasis are more likely to develop distant metastasis including the recurrences at PAN and supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for expression of Sema4c just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with Sema4c-positive lymph node.

Conditions

Interventions

RADIATION

Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer

Sema4c positive+ Para-aortic lymph node metastasis Experimental : Radiation: Extended-field Irradiation (EFI) Prophylactic irradiation of supraclavicular lymph node

RADIATION

Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer

Sema4c positive +Common iliac lymph nodes metastasis Experimental :Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation)

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Ma Ding, M.D. · Tongji Hospital of HUST

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01063387 on ClinicalTrials.gov