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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JYongling, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01175460
First received: July 31, 2010
Last updated: March 4, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Esophageal Cancer
 Drug: S-1, Nedaplatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy [ Time Frame: 3 months per patient ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175460

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Study Chair: Xianghui Du, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: JYongling, MD, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01175460     History of Changes
Other Study ID Numbers: ZhejiangCH08
Study First Received: July 31, 2010
Last Updated: March 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
esophageal Cancer
radiation
s-1
nedaplatin

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Nedaplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013