A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
Study Details
Study Description
Brief Summary
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 3 |
Detailed Description
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Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
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Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
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Patients
A patient will be enrolled when patient have:
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Pathologically diagnosed cervical cancer;
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pelvic or para-aortic lymph metastases, at least match one of following
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CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
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pelvic or para-aortic lymph node shows necrosis or extra capsular spread
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PET/CT scan finds positive pelvic or para-aortic node lymph node
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biopsy confirms lymph metastase
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Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
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Karnofsky Performance Scores ≥ 70;
4.Method
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Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.
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In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: The control group (Group A) In Group A, observation is given after chemoradiation |
Radiation: chemoradiation
radiation with concurrent ciplatin
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| Experimental: The experiment group (Group B) in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks. |
Radiation: chemoradiation
radiation with concurrent ciplatin
Drug: Paclitaxel, Cisplatin
The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.
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Outcome Measures
Primary Outcome Measures
- 3-year progression-free survival (3y-PFS) [3 years after the date of adjuvant chemotherapy completion]
Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion
Secondary Outcome Measures
- Incidence of grade 3/4 adverse event [Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion]
Incidence of patients in a treatment group who manifest a specific adverse event (such as myelosuppression) of grade 3/4. Incidence is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) criteria ver. 4.03.
Other Outcome Measures
- 5-year overall survival (5y-OS) [5 years after the date of adjuvant chemotherapy completion]
Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of adjuvant chemotherapy completion
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically diagnosed cervical cancer;
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pelvic or para-aortic lymph metastases, at least match one of following
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CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
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pelvic or para-aortic lymph node shows necrosis or extra capsular spread
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PET/CT scan finds positive pelvic or para-aortic node lymph node
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biopsy confirms lymph metastase
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Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
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Karnofsky Performance Scores ≥ 70;
Exclusion Criteria:
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Patients with distant metastasis before or during radiotherapy
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Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
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Severe neurological, mental or endocrine diseases
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History of other malignancies
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Those who are considered by the researchers unsuitable to participate -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Affiliated Foshan Hospital | Foshan | Guangdong | China | |
| 2 | Hospital of of Guangdong Armed Police Corps | Guangzhou | Guangdong | China | |
| 3 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | |
| 4 | The First affiliated Hospital of Guangdong Pharmaceutical University | Guangzhou | Guangdong | China | |
| 5 | Guangzhou First People's Hospital | Guanzhou | Guangdong | China | |
| 6 | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China | |
| 7 | Hainan General Hospital | Haikou | Hainan | China | |
| 8 | Xinjiang Medical University Affiliated Tumor Hospital | Ürümqi | Xinjiang | China |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Wei-jun Ye, M.D, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2017-105-01