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

Primary Purpose

Esophageal Neoplasms

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

About this trial

This is an interventional treatment trial for Esophageal Neoplasms

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 < 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.

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

Active Comparator

Placebo Comparator

Arm Label

SIB-IMRT combined chemotherapy followed by chemotherapy

SIB-IMRT Alone followed by chemotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progress free survival（PFS）
Progress free survival（PFS）
Progress free survival（PFS）
Local recurrence-free rate（LRFS）
Local recurrence-free rate（LRFS）
Local recurrence-free rate（LRFS）
Completion Rate
the completion rate of each arm
Adverse events

Full Information

First Posted
October 8, 2017
Last Updated
December 29, 2018
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03308552
Brief Title
Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SIB-IMRT combined chemotherapy followed by chemotherapy
Arm Type
Active Comparator
Arm 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.
Arm Title
SIB-IMRT Alone followed by chemotherapy
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
SIB-IMRT
Intervention Description
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
45-50 mg/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
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months 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 day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
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
Progress free survival（PFS）
Time Frame
1 year
Title
Progress free survival（PFS）
Time Frame
2 year
Title
Progress 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
Description
the completion rate of each arm
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 < 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
+86-13311583220
Email
beryl_wx2000@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Chang, MD
Phone
+86-18801067622
Email
changxiaojlu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zefen Xiao, MD
Organizational Affiliation
The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
Official's Role
Principal Investigator
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
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zefen Xiao, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32962674
Citation
Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.
Results Reference
derived

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

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