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

NCT ID: NCT01175460

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

Brief Summary

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

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemoradiotherapy

Thoracic radiation 60Gy over 30 fractions.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.

Group Type: EXPERIMENTAL

S-1, Nedaplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

JYongling

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianghui Du, MD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZhejiangCH08

Identifier Type: -

Identifier Source: org_study_id