Esophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy; Complications, Chemoradiation
Conditions
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
Interventions
RADIATIONSIB-IMRT
DRUGS-1
Sponsors
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
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| Remission rate of dysphagia | Change from baseline to 1 month after treatment | — |
Other
| Measure | Time frame |
|---|---|
| Clinical target contouring guided by MRI or CT simulation | Baseline |
| 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 |
Countries
China
Outcome results
None listed