Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01175460
Other study ID # ZhejiangCH08
Secondary ID
Status Completed
Phase Phase 1
First received July 31, 2010
Last updated March 4, 2012
Start date January 2010
Est. completion date January 2011

Study information

Verified date March 2012
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.


Description:

Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer.

Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Histologic proof of primary squamous cell or adenocarcinoma of the esophagus

- Locoregionally advanced carcinoma of esophagus without systemic metastases

- Zubrod Performance Status 0-1;

- Patients = 18 years of age;

- No hypersensitivity to E. coli -derived products;

- AGC = 1500/mm3, platelets = 150,000/mm3, Hgb = 10 gm%, serum creatinine = 1.5 mg/dl and/or calculated creatinine clearance = 65 cc/min; serum calcium = 11gm/dl;

- Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free = 5 years;

- No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;

- Written informed consent.

Exclusion Criteria:

- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

- Prior systemic chemotherapy or radiation therapy for esophageal cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
S-1, Nedaplatin
nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 on Days 1-14, repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.

Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment. 3 months per patient Yes
Secondary Objective response rate dependent upon results Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02544737 - Apatinib for Metastatic Esophageal Cancer. Phase 2