Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
NCT ID: NCT04974346
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
455 participants
INTERVENTIONAL
2021-08-02
2030-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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study arm
External beam radiotherapy:
Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.
Concurrent chemotherapy:
Weekly cisplatin 40mg/m2 during external beam radiotherapy.
Brachytherapy:
High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least.
Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
control arm
External beam radiotherapy:
Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.
Concurrent chemotherapy:
Weekly cisplatin 40mg/m2 during external beam radiotherapy.
Brachytherapy:
HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least.
Pelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Interventions
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Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
Pelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Eligibility Criteria
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Inclusion Criteria
* 18-75 female
* Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
* According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
* Cisplatin chemotherapy is acceptable
* Eastern Cooperative Oncology Group(ECOG) score 0-1
* The expected survival was more than 6 months
* Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
* According to the judgment of the researcher, those who can comply with the trial protocol
Exclusion Criteria
* Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
* The patient has received anti-tumor treatment
* Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
* History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
* Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
* Patients with previous pelvic artery embolization
* Previous radiotherapy for pelvic malignant tumor
* There was a history of severe allergic reaction to platinum containing chemotherapy drugs
* Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
* The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
* Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
18 Years
75 Years
FEMALE
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Jinhua Municipal Central Hospital Medical Group
Jinhua, , China
Lishui People's Hospital
Lishui, , China
Ningbo First Hospital
Ningbo, , China
Taizhou Central Hospiatl
Taizhou, , China
Chongqing University Three Gorges Hospital
Wanzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CARTOnG 2101
Identifier Type: -
Identifier Source: org_study_id
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