Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02319187
Other study ID # CH-GI-064
Secondary ID
Status Recruiting
Phase Phase 3
First received December 9, 2014
Last updated July 30, 2015
Start date December 2014
Est. completion date June 2017

Study information

Verified date April 2015
Source Chinese Academy of Medical Sciences
Contact Jing Huang, M.D.
Phone 8610-87788103
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer


Description:

Two arms, phase 3 study of irinotecan plus S1 versus S1 alone in previously treated patients with recurrent or metastatic esophageal cancer. 240 Patients will be enrolled in this trial. The primary objective of this study is to determine the PFS of the two arms. One arm is as follows: irinotecan 160 mg/m2 will be administered as an intravenous infusion over 60 minutes on Days 1, followed by S1 80mg to 120 mg per day on Days 1-10, every 14 days per cycle. The other arm is S1 80mg to 120 mg per day on Days 1-14, every 21 days per cycle.This study will also include the investigation of UGT1A1polymorphisms in the study population.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Histologically proven esophageal squamous cell carcinoma;

- 18 = age = 70;

- ECOG 0-2;

- Previously Treated with platinum or paclitaxel based regimen;

- Uni-dimensionally measurable disease (CT or MRI as per RECIST);

- Patients should have a projected life expectancy of at least 3 months;

- Completion of baseline quality of life questionnaire

- Adequate bone marrow functions (ANC = 1,500/ul, blood platelet = 100,000/ul, haemoglobin = 10g/dl);

- Adequate renal functions(serum creatinine = 1.5mg/dl)

- liver functions (serum bilirubin = 1.5UNL, AST/ALT = 3 times(normal value)

- Written informed consent

Exclusion Criteria:

- Previous chemotherapy with 5-FU or irinotecan after recurrence or metastasis;

- adjuvant chemotherapy with 5-FU-based chemotherapy within 6 months prior to the start of study treatment;

- Active infection requiring antibiotics

- Pregnant, lactating women

- Psychiatric illness, epileptic disorders

- Concurrent systemic illness not appropriate for chemotherapy

- History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
S1
S1 80mg to 120 mg per day on Days 1-14, every 21 days
S-1
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecan
irinotecan 160mg/m2 d1, every 14 days

Locations

Country Name City State
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing
China Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine Changsha
China Mongolia Chifeng Hospital Chifeng Inner Mongolia
China Herbin Medical University Cancer Hospital Herbin
China Ordos Central Hospital Ordos Inner Mongolia
China Hebei four Hospital Shijiazhuang Hebei
China Shanxi Province Cancer Hospital Taiyuan Shanxi
China Jiangsu Taizhou peoples Hospital Taizhou Jiangsu
China Tongji Hospital, Tongji Medical College Wuhan Hubei
China Qinghai Cancer Hosptal Xining Qinghai
China The First Affiliated Hospital of Xinxiang Medical College Xinxiang Henan
China Henan Cancer Hospital Zhengzhou
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival 2 No
Secondary Adverse Events 2 year No
Secondary overall survival 3 year No
Secondary response rate 1.5 year No
Secondary quality of life 2 year No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05013697 - TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer. Phase 2
Completed NCT02253602 - Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer N/A
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01900691 - Removal of the Evolution® Esophageal Stent - Fully Covered N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT00760604 - A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer Phase 3
Completed NCT00160030 - Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer Phase 2
Suspended NCT00048529 - Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Terminated NCT03223662 - Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy Phase 2
Completed NCT05680077 - KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Completed NCT03549494 - Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction Phase 2
Completed NCT03261947 - A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors Phase 2
Terminated NCT00094978 - Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum Phase 1
Recruiting NCT02908204 - Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma N/A
Completed NCT02378948 - Nutritional Route In Esophageal Resection Trial II N/A
Completed NCT02703142 - Endoscopic Evaluation After Esophagectomy N/A
Recruiting NCT02604615 - The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy Phase 3