S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175460
• Other study ID #: ZhejiangCH08
• 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

• Esophageal Cancer
• Esophageal Neoplasms

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