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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02979691

Collaborator

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

350

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Esophagus Cancer Esophagogastric Junction Cancer Radiotherapy; Complications Chemoradiation	Radiation: SIB-IMRT Drug: S-1	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival [1 year]

Secondary Outcome Measures

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]
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]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing		China	100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zefen Xiao, Dr., Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02979691

Other Study ID Numbers:

3JECROG P-01

First Posted:

Dec 2, 2016

Last Update Posted:

Jul 21, 2020

Last Verified:

Jul 1, 2020

Additional relevant MeSH terms:

Esophageal Neoplasms

Study Results

No Results Posted as of Jul 21, 2020