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A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Female
Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis

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Trial Information

A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis


Inclusion Criteria:



1. Patients (who have been adequately clinically staged) with primary, untreated,
histologically confirmed carcinoma of the uterine cervix (including clear cell and
small cell carcinoma), with metastatic lymphadenopathies (any of pelvis or PAN >1.5
cm in short diameter, with/without biopsy proven inguinal lymph node [ING])

2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2

3. Patients with adequate bone marrow function: absolute neutrophil count (ANC) greater
than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the
beginning.

4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.

5. Patients who have signed an approved informed consent and authorization

Exclusion Criteria:

1. Patients with recurrent LN(s) which was(were) previously irradiated.

2. Patients who have diagnosis of other malignance tumors except papillary or follicular
thyroid cancer or skin cancer

3. Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g.
supraclavicular or mediastinal metastatic lymphadenopathy)

4. Patients with distant organ metastasis (e.g. bone, lung, brain…)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

From date of initiation of radiotherapy until the date of documented date of death from any cause, assessed up to 3 years

Outcome Time Frame:

documented data of death, up to 3 years

Safety Issue:

No

Principal Investigator

Jooyoung Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS 12-615

NCT ID:

NCT01730651

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis
  • cervical cancer with metastatic lymphadenopathies at initial diagnosis
  • Uterine Cervical Neoplasms
  • Lymphatic Diseases

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