Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03

Phase 3

• Conditions: IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer
• Interventions: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug; Other: Involved Field Irradiation (IFI)

• Registration Number: NCT03328234
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-28
• Study First Submitted QC: 2017-10-28
• Study First Posted: 2017-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-29
• Last Update Posted: 2019-01-02
• Primary Completion: 2021-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Age<70
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIB-IMRT combined chemotherapy with IFI	Involved Field Irradiation (IFI)	-
SIB-IMRT with IFI	Involved Field Irradiation (IFI)	-
SIB-IMRT combined chemotherapy with IFI	Platinum-Based Drug	-
SIB-IMRT with IFI	SIB-IMRT	-
SIB-IMRT combined chemotherapy with IFI	SIB-IMRT	-
SIB-IMRT with IFI	Platinum-Based Drug	-
SIB-IMRT combined chemotherapy with IFI	Paclitaxel	-
SIB-IMRT with IFI	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 year

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 5 year
Progression-free survival (PFS)	3 year
Completion Rate	up to 2 year
Local recurrence-free rate（LRFS）	3 year

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC); 🇨🇳 Beijing, China