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

February 4, 2010 updated by: Huazhong University of Science and Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of HUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB? with only unilateral pelvic wall extension
  • Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
  • Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
  • Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
  • Patients who have signed an approved informed consent and authorization
  • Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
  • Age: 18≤age≤80

Exclusion Criteria:

  • Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
  • Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
  • Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non-malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Sema4c positive +Common iliac lymph nodes control
Sema4c Positive & "Radical hysterectomy +Pelvic Radiotherapy "
ACTIVE_COMPARATOR: Sema4c positive +Common iliac lymph nodes Experimental
Sema4c Positive & "Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) "
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)
NO_INTERVENTION: Sema4c Positive + PAN positive control arm
Sema4c Positive & " Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) "
EXPERIMENTAL: Sema4c positive+ PAN positive Experimental
Sema4c Positive & Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation+ supraclavicular lymph nodes irradiation) '
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes, supraclavicular lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (ESTIMATE)

February 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM2010-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe