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

NCT01175460 | Completed Phase 1 DMC

• 1 other identifier: ZhejiangCH08
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Keywords

esophageal Cancer; radiation; s-1; nedaplatin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Objective response rate

  dependent upon results

Study Arms (1)

Chemoradiotherapy

EXPERIMENTAL

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.

Drug: S-1, Nedaplatin

Interventions

S-1, Nedaplatin 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.

Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination); nedaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Xianghui Du, MD

  Zhejiang Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2010
• First Posted: August 4, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

CN (1)