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

Esophageal Neoplasms Clinical Trial

Official title:

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 Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308552
• Other study ID #: 3JECROG P-02
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Xin Wang, MD
• Phone: +86-13311583220
• Email: beryl_wx2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Lymphatic Metastasis

Intervention

Radiation:
• SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f

Drug:
• Paclitaxel
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
• Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
• Paclitaxel
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
• Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Affiliated Hospital of Hebei University, Anyang Tumor Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival(OS)		1 year
Primary	Overall survival(OS)		2 year
Primary	Overall survival(OS)		3 year
Secondary	Progress free survival(PFS)		1 year
Secondary	Progress free survival(PFS)		2 year
Secondary	Progress free survival(PFS)		3 year
Secondary	Local recurrence-free rate(LRFS)		1 year
Secondary	Local recurrence-free rate(LRFS)		2 year
Secondary	Local recurrence-free rate(LRFS)		3 year
Secondary	Completion Rate	the completion rate of each arm	up to 2 year
Secondary	Adverse events		up to 5 year