Cervical Cancer Clinical Trial
Official title:
A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis.
Verified date | September 2020 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II study of high dose intensity modulated radiation therapy in the cervical cancer with metastatic lymphadenopathies at initial diagnosis
Status | Active, not recruiting |
Enrollment | 55 |
Est. completion date | July 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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…) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center, Korea | Goyang-si | Gyeonggi-do |
Korea, Republic of | National Cancer Center | Goyang-si, | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea | Keimyung University Dongsan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | RTOG acute and late Toxicity | ? Acute: gastrointestinal (GI), genitourinary (GU), bone marrow (BM) ? Late: GI, GU, lower extremity edema, treatment-related neuropathy, bone density change |
every follow-up date, up to 3 years | |
Primary | Overall survival | From date of initiation of radiotherapy until the date of documented date of death from any cause, assessed up to 3 years | documented data of death, up to 3 years | |
Secondary | Disease-free survival (DFS) | From date of initiation of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. Progression-free survival of lymph nodes(LNs) treated with high dose ? Regional LN (other than the LNs treated with high dose) failure-free survival ? Distant organ (other than para-aortic LNs[PAN]) failure-free survival |
documented date of progression or death, up to 3 years |
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