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

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)

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

Study Overview

• Status: Completed
• Conditions: Chemoradiation; Esophagus Cancer; Radiotherapy; Complications; Esophagogastric Junction Cancer
• Intervention / Treatment: Radiation: SIB-IMRT; Drug: S-1

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SIB-IMRT; 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).	Radiation: SIB-IMRT
Experimental: S1 based SIB-IMRT; 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.	Radiation: SIB-IMRT; Drug: S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival		1 year
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.	Baseline
Remission rate of dysphagia		Change from baseline to 1 month after treatment
Time of locoregional control and failure site within or outside radiation field		1 year
Radiotherapy toxicities		2 months
Chemoradiotherapy toxicities		2 months

Other Outcome Measures

Outcome Measure	Time Frame
Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects	6 months
CT/MRI Texture Features in evaluating the tumor response and prognosis	Change from baseline to 1 month after treatment
Clinical target contouring guided by MRI or CT simulation	Baseline

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Fujian Cancer Hospital; Tianjin Medical University Cancer Institute and Hospital; The First Affiliated Hospital of Zhengzhou University; Affiliated Hospital of Hebei University; Hebei Medical University Fourth Hospital; The Affiliated Hospital of Inner Mongolia Medical University; Anyang Tumor Hospital; Tengzhou Central People's Hospital; Sichuan Cancer Hospital and Research Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 18, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 3JECROG P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No