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

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ClinicalTrials.gov Identifier: NCT01175460
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
JYongling, Zhejiang Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: S-1, Nedaplatin Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy [ Time Frame: 3 months per patient ]
    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 :
  1. Objective response rate [ Time Frame: dependent upon results ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: JYongling, MD, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01175460     History of Changes
Other Study ID Numbers: ZhejiangCH08
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

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

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