Condition or disease | Intervention/treatment | Phase |
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Uterine Cervical Neoplasms | Radiation: Prophylactic extended-field Irradiation Radiation: Pelvic irradiation Radiation: Intracavitary brachytherapy Drug: Concurrent chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 638 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial |
Actual Study Start Date : | June 17, 2019 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | June 1, 2025 |
Arm | Intervention/treatment |
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Active Comparator: 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.
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Radiation: Pelvic irradiation
CTV covers pelvis.
Other Name: Pelvic radiotherapy
Radiation: 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.
Other Name: Brachytherapy
Drug: Concurrent chemotherapy Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Other Name: Chemotherapy
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Experimental: 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.
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Radiation: Prophylactic extended-field Irradiation
CTV covers pelvis and para-aortic lymph nodes region.
Other Name: Prophylactic radiotherapy for para-aortic lymph nodes region
Radiation: 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.
Other Name: Brachytherapy
Drug: Concurrent chemotherapy Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Other Name: Chemotherapy
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least meet one of the following characteristics:
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.
Exclusion Criteria:
Contact: Ke Hu | +86-01069155487 | huk@pumch.cn |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Ke Hu, MD 010-69155482 huk@pumch.cn | |
Contact: Weiping Wang, PhD 010-69155483 jluwangweiping@163.com | |
China, Shanxi | |
First Affiliated Hospital Xi'an Jiaotong University | Recruiting |
Xi'an, Shanxi, China | |
Contact: Zi Liu |
Principal Investigator: | Ke Hu | Peking Union Medical College Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 11, 2019 | ||||
First Posted Date ICMJE | May 20, 2019 | ||||
Last Update Posted Date | August 7, 2019 | ||||
Actual Study Start Date ICMJE | June 17, 2019 | ||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: 3-year ] Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer | ||||
Official Title ICMJE | Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial | ||||
Brief Summary | To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT). | ||||
Detailed Description | This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Uterine Cervical Neoplasms | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
638 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2025 | ||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03955367 | ||||
Other Study ID Numbers ICMJE | PUMCH-EFI | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Ke Hu, Peking Union Medical College Hospital | ||||
Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Peking Union Medical College Hospital | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |