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

Primary Purpose

IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SIB-IMRT
Paclitaxel
Platinum-Based Drug
Paclitaxel
Platinum-Based Drug
Involved Field Irradiation (IFI)
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SIB-IMRT combined chemotherapy with IFI

SIB-IMRT with IFI

Arm Description

Outcomes

Primary Outcome Measures

Overall survival (OS)
Overall survival (OS)
Overall survival (OS)

Secondary Outcome Measures

Progression-free survival (PFS)
Progression-free survival (PFS)
Progression-free survival (PFS)
Local recurrence-free rate（LRFS）
Local recurrence-free rate（LRFS）
Local recurrence-free rate（LRFS）
Completion Rate
Adverse events

Full Information

First Posted
October 28, 2017
Last Updated
December 29, 2018
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03328234
Brief Title
Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIB-IMRT combined chemotherapy with IFI
Arm Type
Experimental
Arm Title
SIB-IMRT with IFI
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
SIB-IMRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Intervention Type
Drug
Intervention Name(s)
Platinum-Based Drug
Intervention Description
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Intervention Type
Drug
Intervention Name(s)
Platinum-Based Drug
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Involved Field Irradiation (IFI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
1 year
Title
Overall survival (OS)
Time Frame
2 year
Title
Overall survival (OS)
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
1 year
Title
Progression-free survival (PFS)
Time Frame
2 year
Title
Progression-free survival (PFS)
Time Frame
3 year
Title
Local recurrence-free rate（LRFS）
Time Frame
1 year
Title
Local recurrence-free rate（LRFS）
Time Frame
2 year
Title
Local recurrence-free rate（LRFS）
Time Frame
3 year
Title
Completion Rate
Time Frame
up to 2 year
Title
Adverse events
Time Frame
up to 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
+86-13311583220
Email
beryl_wx2000@163.com
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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