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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


Phase 1
18 Years
80 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Ma Ding, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Tongji Hospital of HUST

Authority:

China: Ministry of Health

Study ID:

GM2010-022

NCT ID:

NCT01063387

Start Date:

January 2010

Completion Date:

February 2015

Related Keywords:

  • Cervical Cancer
  • cervical cancer,semaphorin 4C (Sema4C),
  • Prophylactic Irradiation
  • Uterine Cervical Neoplasms

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