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

Phase 3

• Conditions: Esophageal Neoplasms
• Interventions: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug

• Registration Number: NCT03308552
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-08
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-12
• Study Start: 2017-12-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-29
• Last Update Posted: 2019-01-02
• Primary Completion: 2020-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIB-IMRT combined chemotherapy followed by chemotherapy	Platinum-Based Drug	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 combined chemotherapy followed by chemotherapy	SIB-IMRT	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 Alone followed by chemotherapy	SIB-IMRT	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 Alone followed by chemotherapy	Platinum-Based Drug	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 combined chemotherapy followed by chemotherapy	Paclitaxel	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 Alone followed by chemotherapy	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 year

Secondary Outcome Measures

Name	Time	Method
Progress free survival（PFS）	3 year
Local recurrence-free rate（LRFS）	3 year
Completion Rate	up to 2 year	the completion rate of each arm
Adverse events	up to 5 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, Beijing, China