NCT03328234UnknownPhase 3
A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03
Chinese Academy of Medical Sciences1 site in 1 country2 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Study Overview
Brief Summary
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Age≥ 70 or ≤ 16
- •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.
Arms & Interventions
SIB-IMRT combined chemotherapy with IFI
Experimental
Intervention: SIB-IMRT (Radiation)
SIB-IMRT combined chemotherapy with IFI
Experimental
Intervention: Paclitaxel (Drug)
SIB-IMRT combined chemotherapy with IFI
Experimental
Intervention: Platinum-Based Drug (Drug)
SIB-IMRT combined chemotherapy with IFI
Experimental
Intervention: Involved Field Irradiation (IFI) (Other)
SIB-IMRT with IFI
Experimental
Intervention: SIB-IMRT (Radiation)
SIB-IMRT with IFI
Experimental
Intervention: Paclitaxel (Drug)
SIB-IMRT with IFI
Experimental
Intervention: Platinum-Based Drug (Drug)
SIB-IMRT with IFI
Experimental
Intervention: Involved Field Irradiation (IFI) (Other)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: 3 year
Secondary Outcomes
- Progression-free survival (PFS)(3 year)
- Completion Rate(up to 2 year)
- Adverse events(up to 5 year)
- Local recurrence-free rate（LRFS）(3 year)
Investigators
Zefen Xiao
Pricipal investigator
Chinese Academy of Medical Sciences
Study Sites (1)
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