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

IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer 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 Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03328234
• Other study ID #: 3JECROG P-03
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: December 31, 2022

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2021
• 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 = 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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer
• Lymphatic Metastasis

Intervention

Radiation:
• 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.

Drug:
• Paclitaxel
45-50mg/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
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
• Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy

Other:
• Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.

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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

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	Progression-free survival (PFS)		1 year
Secondary	Progression-free survival (PFS)		2 year
Secondary	Progression-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		up to 2 year
Secondary	Adverse events		up to 5 year