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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Treatments: Radiation: SIB-IMRT; Other: Involved Field Irradiation (IFI); Drug: Paclitaxel; Drug: Platinum-Based Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03328234

3JECROG P-03

Details and patient eligibility

About

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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

SIB-IMRT combined chemotherapy with IFI

Experimental group

Treatment:

Drug: Platinum-Based Drug

Drug: Paclitaxel

Other: Involved Field Irradiation (IFI)

Radiation: SIB-IMRT

SIB-IMRT with IFI

Experimental group

Treatment:

Drug: Platinum-Based Drug

Drug: Paclitaxel

Other: Involved Field Irradiation (IFI)

Radiation: SIB-IMRT