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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01063387
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01063387

Locations
China, Hubei
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
  More Information

No publications provided

Responsible Party: Ding Ma, Cancer Biology Research Center of Tongji Hospital
ClinicalTrials.gov Identifier: NCT01063387     History of Changes
Other Study ID Numbers: GM2010-022
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
cervical cancer,semaphorin 4C (Sema4C),
Prophylactic Irradiation

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014