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

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Unknown status
CT.gov ID
NCT01063387
Collaborator
(none)
200
1
4
61
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer
  • Radiation: Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Feb 1, 2015
Anticipated Study Completion Date :
Feb 1, 2015

Arms and Interventions

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 +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

Outcome Measures

Primary Outcome Measures

  1. 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 [5 years]

Secondary Outcome Measures

  1. To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital of HUST Wuhan Hubei China

Sponsors and Collaborators

  • Huazhong University of Science and Technology

Investigators

  • Study Director: Ma Ding, M.D., Tongji Hospital of HUST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01063387
Other Study ID Numbers:
  • GM2010-022
First Posted:
Feb 5, 2010
Last Update Posted:
Feb 5, 2010
Last Verified:
Feb 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2010