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

Esophagus Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979691
• Other study ID #: 3JECROG P-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2016
• Est. completion date: April 2020

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiation
• Esophageal Neoplasms
• Esophagogastric Junction Cancer
• Esophagus Cancer
• Radiotherapy; Complications

Intervention

Radiation:
• SIB-IMRT

Drug:
• S-1

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (11)

Lead Sponsor

Collaborator

Chinese Academy of Medical Sciences

Affiliated Hospital of Hebei University, Anyang Tumor Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, Sichuan Cancer Hospital and Research Institute, Tengzhou Central People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects		6 months
Other	CT/MRI Texture Features in evaluating the tumor response and prognosis		Change from baseline to 1 month after treatment
Other	Clinical target contouring guided by MRI or CT simulation		Baseline
Primary	Overall survival		1 year
Secondary	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
Secondary	Remission rate of dysphagia		Change from baseline to 1 month after treatment
Secondary	Progression free survival		1 year
Secondary	Time of locoregional control and failure site within or outside radiation field		1 year
Secondary	Radiotherapy toxicities		2 months
Secondary	Chemoradiotherapy toxicities		2 months