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

NCT ID: NCT01063387

Last Updated: 2010-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-02-28

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sema4c positive +Common iliac lymph nodes control

Sema4c Positive \& "Radical hysterectomy +Pelvic Radiotherapy "

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sema4c positive +Common iliac lymph nodes Experimental

Sema4c Positive \& "Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) "

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: RADIATION

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

Sema4c Positive + PAN positive control arm

Sema4c Positive \& " Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) "

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sema4c positive+ PAN positive Experimental

Sema4c Positive \& Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation+ supraclavicular lymph nodes irradiation) '

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: 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)

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Cancer Biology Research Center of Tongji Hospital

Principal Investigators

Ma Ding, M.D.

Role: STUDY_DIRECTOR

Tongji Hospital of HUST

Locations

Tongji Hospital of HUST

Wuhan, Hubei, China

Countries

China

Other Identifiers

GM2010-022

Identifier Type: -

Identifier Source: org_study_id