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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Esophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy; Complications, Chemoradiation

Intervention / Treatment
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* Radiation: SIB-IMRT
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SIB-IMRT<br>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<br> <br> |
| Experimental: S1 based SIB-IMRT<br>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<br> <br> Drug: S-1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Progression free survival |  | 1 year | 
| Time of locoregional control and failure site within or outside radiation field |  | 1 year | 
| Radiotherapy toxicities |  | 2 months | 
| Chemoradiotherapy toxicities |  | 2 months |