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Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

Primary Purpose

Esophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy; Complications

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SIB-IMRT
S-1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥70 years
  • Esophageal or Esophagogastric cancer
  • Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
  • Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
  • No distant metastasis other than supraclavicular lymph nodes
  • No prior history of thoracic radiation
  • Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
  • Informed consent

Exclusion Criteria:

  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
  • With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
  • History of allergic reactions attributed to similar chemical or biologic complex to S-1
  • With esophageal fistula, perforation, cachexia prior to treatment
  • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
  • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
  • Pregnant or lactating females

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SIB-IMRT

S1 based SIB-IMRT

Arm Description

SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).

S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Comprehensive geriatric assessment
A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation in which multiple problems of older persons are described.It consists several questionnaires used to assess an older individual's functional status,comorbid medical condition,cognition, psychologic state, social support, and nutritional status,etc.
Remission rate of dysphagia
Progression free survival
Time of locoregional control and failure site within or outside radiation field
Radiotherapy toxicities
Chemoradiotherapy toxicities

Full Information

First Posted
November 22, 2016
Last Updated
July 18, 2020
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, Tengzhou Central People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Inner Mongolia Medical University, Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02979691
Brief Title
Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01
Official Title
A Phase II/III Study Comparing Simultaneous Integrated Boost (SIB) Intensity Modulated Radiation Therapy (IMRT) With S1 Based SIB-IMRT Followed by Adjuvant Chemotherapy With S1 in Elderly Patients With Esophageal or Esophagogastric Cancer (3JECROG-P01)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

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, Tengzhou Central People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Inner Mongolia Medical University, Sichuan Cancer Hospital and Research Institute

4. Oversight

5. Study Description

Brief Summary
Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy; Complications, Chemoradiation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SIB-IMRT
Arm Type
Active Comparator
Arm Description
SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).
Arm Title
S1 based SIB-IMRT
Arm Type
Experimental
Arm Description
S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
SIB-IMRT
Intervention Type
Drug
Intervention Name(s)
S-1
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comprehensive geriatric assessment
Description
A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation in which multiple problems of older persons are described.It consists several questionnaires used to assess an older individual's functional status,comorbid medical condition,cognition, psychologic state, social support, and nutritional status,etc.
Time Frame
Baseline
Title
Remission rate of dysphagia
Time Frame
Change from baseline to 1 month after treatment
Title
Progression free survival
Time Frame
1 year
Title
Time of locoregional control and failure site within or outside radiation field
Time Frame
1 year
Title
Radiotherapy toxicities
Time Frame
2 months
Title
Chemoradiotherapy toxicities
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects
Time Frame
6 months
Title
CT/MRI Texture Features in evaluating the tumor response and prognosis
Time Frame
Change from baseline to 1 month after treatment
Title
Clinical target contouring guided by MRI or CT simulation
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥70 years Esophageal or Esophagogastric cancer Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis) Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3 No distant metastasis other than supraclavicular lymph nodes No prior history of thoracic radiation Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits Informed consent Exclusion Criteria: Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc History of allergic reactions attributed to similar chemical or biologic complex to S-1 With esophageal fistula, perforation, cachexia prior to treatment Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of myocardial infarction within the past 6 months or history of ventricular arrhythmia Pregnant or lactating females
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
32983991
Citation
Wang X, Ge X, Wang X, Zhang W, Zhou H, Lin Y, Qie S, Hu M, Wang W, Liu K, Pang Q, Li M, Chen J, Liu M, Zhang K, Li L, Shi Y, Deng W, Li C, Ni W, Chang X, Han W, Deng L, Wang W, Liang J, Bi N, Zhang T, Liu W, Wang J, Zhai Y, Feng Q, Chen D, Zhou Z, Zhao Y, Sun X, Xiao Z. S-1-Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial. Front Oncol. 2020 Aug 28;10:1499. doi: 10.3389/fonc.2020.01499. eCollection 2020.
Results Reference
derived
PubMed Identifier
31036088
Citation
Li C, Wang X, Wang X, Han C, Wang P, Pang Q, Chen J, Sun X, Wang L, Zhang W, Lin Y, Ge X, Zhou Z, Ni W, Chang X, Liang J, Deng L, Wang W, Zhao Y, Xiao Z. A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol. BMC Cancer. 2019 Apr 29;19(1):397. doi: 10.1186/s12885-019-5544-1. Erratum In: BMC Cancer. 2019 May 23;19(1):492.
Results Reference
derived

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Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

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