Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer
NCT ID: NCT03955367
Last Updated: 2022-02-23
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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UNKNOWN
PHASE3
638 participants
INTERVENTIONAL
2019-06-17
2025-06-01
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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Pelvic Irradiation
Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.
Pelvic irradiation
CTV covers pelvis.
Intracavitary brachytherapy
The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.
Concurrent chemotherapy
Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Prophylactic EFI
Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.
Prophylactic extended-field Irradiation
CTV covers pelvis and para-aortic lymph nodes region.
Intracavitary brachytherapy
The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.
Concurrent chemotherapy
Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Interventions
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Prophylactic extended-field Irradiation
CTV covers pelvis and para-aortic lymph nodes region.
Pelvic irradiation
CTV covers pelvis.
Intracavitary brachytherapy
The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.
Concurrent chemotherapy
Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years and ≤ 70 years.
3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
4. No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.\*
5. No evidence of distant metastasis (FIGO stage IVB).
6. At least meet one of the following characteristics:
1. Number of pelvic MLNs ≥ 2;
2. Short diameter of pelvic MLNs ≥ 1.5cm; \*
3. Parametrial involvement to the pelvic wall ＃.
7. Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.
8. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
9. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).
* MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.
* Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;
Exclusion Criteria
2. Tumor extended to the lower third of the vagina.
3. Tumor spread to mucosa of the bladder or rectum.
4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
5. Prior malignancy.
6. History of previous radiotherapy to the abdomen or pelvis.
7. Pregnancy or lactation.
8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
9. Active infection with fever.
10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
18 Years
70 Years
FEMALE
No
Sponsors
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Peking University First Hospital
OTHER
Cangzhou Central Hospital
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Gansu Wuwei Tumor Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Harbin Medical University Third Affiliated Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Guizhou Provincial People's Hospital
OTHER
Second Hospital of Jilin University
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
940 Hospital of the People's Liberation Army Joint Logistic Support Force
OTHER
General Hospital of Benxi Iron & Steel Industry Group
UNKNOWN
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
General Hospital of Ningxia Medical University
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Tangshan People's Hospital
OTHER
Zhongnan Hospital
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
The Affiliated Tumor Hospital of Xinjiang Medical University
UNKNOWN
Zhejiang Cancer Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Affiliated Cancer Hospital of Zhengzhou University
UNKNOWN
Seventh Medical Center of PLA Army General Hospital
OTHER
Shengjing Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Xiangya Hospital of Central South University
OTHER
Henan Provincial People's Hospital
OTHER
Xi'an Gaoxin Hospital
OTHER
West China Second University Hospital
OTHER
The Forth Affiliated Hospital of Guangxi Medical University
UNKNOWN
Peking Union Medical College Hospital
OTHER
Responsible Party
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Ke Hu
Vice director of Radiation Oncology Department
Principal Investigators
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Ke Hu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Zi Liu
Role: primary
References
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Wang W, Liu X, Meng Q, Zhang F, Hu K. Prophylactic Extended-Field Irradiation for Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Propensity-Score Matching Analysis. Int J Gynecol Cancer. 2018 Oct;28(8):1584-1591. doi: 10.1097/IGC.0000000000001344.
Other Identifiers
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PUMCH-EFI
Identifier Type: -
Identifier Source: org_study_id
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