S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

• ClinicalTrials.gov Identifier: NCT02913066
• Recruitment Status: Unknown
• First Posted: September 23, 2016
• Last Update Posted: June 16, 2017
• Sponsor: Mianyang Central Hospital
• Information provided by (Responsible Party): Xiaobo Du, Mianyang Central Hospital

Tracking Information

• First Submitted Date: September 20, 2016
• First Posted Date: September 23, 2016
• Last Update Posted Date: June 16, 2017
• Study Start Date: September 2016
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2017)

Complete Remission Rate (CR) [ Time Frame: Three months after radiotherapy finished ]

Complete response rate of primary tumor which will be measured by endoscopy and computer tomography

• Original Primary Outcome Measures (submitted: September 22, 2016): Complete Remission Rate (CR) [ Time Frame: Three months after radiotherapy finished ]

Current Secondary Outcome Measures (submitted: June 14, 2017)

• Overall Survival (OS) [ Time Frame: Two years after adjuvant chemotherapy finished ]
  The time from treatment completion to patient death
• Progression-Free-Survival (PFS) [ Time Frame: Two years after adjuvant chemotherapy finished ]
  The time from treatment completion to disease progression

Original Secondary Outcome Measures (submitted: September 22, 2016)

• Overall Survival (OS) [ Time Frame: Three years after adjuvant chemotherapy finished ]
• Progression-Free-Survival (PFS) [ Time Frame: Three years after adjuvant chemotherapy finished ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
• Official Title: Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Brief Summary

Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy.

Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Detailed Description

Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy;

control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.

Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

Primary Outcome Measure is complete remission rate.

Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Esophageal Squamous Cell Carcinoma

Intervention

• Other: S-1 concurrent radiotherapy
  Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle.
• Other: S-1 plus Cisplatin concurrent radiotherapy
  Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

Study Arms

• Experimental: Single drug
  S-1 concurrent Radiotherapy
  Intervention: Other: S-1 concurrent radiotherapy
• Active Comparator: Double drug
  S-1 plus cisplatin concurrent Radiotherapy
  Intervention: Other: S-1 plus Cisplatin concurrent radiotherapy

• Publications *: Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 14, 2017): 88
• Original Estimated Enrollment (submitted: September 22, 2016): 253
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Histology or cytology confirmed esophageal squamous cell carcinoma.
2. There are measurable lesions in the RECIST standard.
3. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
4. Age younger than 75 years old.
5. Eastern Cooperative Oncology Group physical status score was 0 ~ 1.
6. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.
7. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.
8. Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L.
9. Cr≤1.25 upper normal limit or CCr≥60 mL/min.
10. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.
11. A history of interstitial pneumonia and interstitial pneumonia.
12. FEV1>0.8 liters.
13. Patients or family members signed a formal informed consent.

Exclusion Criteria:

1. Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
2. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
3. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
4. Patients with distant metastases.
5. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
6. Can't understand the test requirements, or patients may not comply with the requirements of the test.
7. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.
8. An allergic reaction known to have 3 or 4 levels of any treatment.
9. Had participated in other clinical trials in the past 30 days.
10. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02913066
• Other Study ID Numbers: XDu
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Xiaobo Du, Mianyang Central Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Mianyang Central Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bo Du X, Doctor; Mianyang Central Hospital

• PRS Account: Mianyang Central Hospital
• Verification Date: June 2017