Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Esophageal Neoplasms

Treatments: Drug: Platinum-Based Drug; Drug: Paclitaxel; Radiation: SIB-IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03308552

3JECROG P-02

Details and patient eligibility

About

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

Enrollment: 164 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 < 18
• 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: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups, including a placebo group

SIB-IMRT combined chemotherapy followed by chemotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: SIB-IMRT

Drug: Paclitaxel

Drug: Platinum-Based Drug

SIB-IMRT Alone followed by chemotherapy

Placebo Comparator group

Description:

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.

Treatment:

Radiation: SIB-IMRT

Drug: Paclitaxel

Drug: Platinum-Based Drug