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

NCT01063387 | Unknown Phase 1 DMC

• 1 other identifier: GM2010-022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

cervical cancer,semaphorin 4C (Sema4C),; Prophylactic Irradiation

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (4)

Sema4c positive +Common iliac lymph nodes control

NO INTERVENTION

Sema4c Positive \& "Radical hysterectomy +Pelvic Radiotherapy "

Sema4c positive +Common iliac lymph nodes Experimental

ACTIVE COMPARATOR

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 + PAN positive control arm

NO INTERVENTION

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

Sema4c positive+ PAN positive Experimental

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

Interventions

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

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

Sema4c positive+ PAN positive Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital of HUST

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ma Ding, M.D.

  Tongji Hospital of HUST

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

CN (1)