Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
NCT ID: NCT03308552
Last Updated: 2019-01-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
164 participants
INTERVENTIONAL
2017-12-01
2021-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy for Locally Advanced Esophageal Carcinoma
NCT02429622
Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01
NCT02979691
Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma
NCT02858206
High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
NCT03535207
Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma
NCT01752205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SIB-IMRT combined chemotherapy followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Paclitaxel
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Paclitaxel
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Paclitaxel
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Paclitaxel
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Paclitaxel
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
* A untreated squamous esophageal carcinoma
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* Adequate organ function
* No known history of drug allergy
* Blood routine examination : WBC≥4.0
* hepatic and renal function are normal
Exclusion Criteria
* Already received the treatment of chemotherapy or radiotherapy
* Pregnant or lactating females
* Known drug allergy
* Without agreement of informed consent form
* Insufficient hepatorenal function or Blood routine examination
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
18 Years
69 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hebei Medical University Fourth Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Anyang Tumor Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Affiliated Hospital of Hebei University
OTHER
Fujian Cancer Hospital
OTHER_GOV
Sichuan Cancer Hospital and Research Institute
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zefen Xiao
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zefen Xiao, MD
Role: PRINCIPAL_INVESTIGATOR
The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zefen Xiao, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3JECROG P-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.