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

Phase 2

Completed

• Conditions: Radiotherapy; Complications; Esophagus Cancer; Esophagogastric Junction Cancer; Chemoradiation
• Interventions: Radiation: SIB-IMRT; Drug: S-1

• Registration Number: NCT02979691
• Lead Sponsor: Chinese Academy of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-02
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S1 based SIB-IMRT	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.
SIB-IMRT	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).
S1 based SIB-IMRT	S-1	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
Radiotherapy toxicities	2 months
Remission rate of dysphagia	Change from baseline to 1 month after treatment
Chemoradiotherapy toxicities	2 months
Comprehensive geriatric assessment	Baseline	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.
Progression free survival	1 year
Time of locoregional control and failure site within or outside radiation field	1 year

Trial Locations

Locations (1)

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