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Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

Primary Purpose

Esophageal Cancer, Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

CDGP/5-FU combined with radiation

Radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, Nedaplatin, 5-FU, chemotherapy, radiation, chemoradiotherapy

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: newly diagnosed cases histologically as squamous cell carcinoma, a performance status 0 to 2, white blood cells >3,000/microL, platelets >100,000/microL, serum total bilirubin <2.0 mg/dl, serum transaminase <3 times the upper normal limit, serum creatinine <1.5 mg/dl, creatinine clearance >60 ml/min Exclusion Criteria: serious cardiac disease prior chemotherapy and radiotherapy

Sites / Locations

First Department of Medicine, Hamamatsu University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Chemoradiotherapy

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Adverse events

Survival rate

Full Information

NCT ID

NCT00197444

First Posted

September 13, 2005

Last Updated

February 19, 2009

Sponsor

Hamamatsu University

1. Study Identification

Unique Protocol Identification Number

NCT00197444

Brief Title

Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

Official Title

A Phase II Study of Daily Low-Dose of Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum) and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hamamatsu University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma.

Detailed Description

The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan, endoscopic ultrasonography (EUS), endoscopy and esophagography. Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Squamous Cell Carcinoma

Keywords

esophageal cancer, Nedaplatin, 5-FU, chemotherapy, radiation, chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

CDGP/5-FU combined with radiation

Other Intervention Name(s)

Nedaplatin, 5-FU

Intervention Description

Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Radiation

Intervention Description

Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.

Primary Outcome Measure Information:

Title

Response rate

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

every 3-6 months

Title

Survival rate

Time Frame

every 3-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satoshi Osawa, M.D.

Organizational Affiliation

First Department of Medicine, Hamamatsu University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Department of Medicine, Hamamatsu University School of Medicine

City

Hamamatsu

ZIP/Postal Code

431-3192

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19930599

Citation

Osawa S, Furuta T, Sugimoto K, Kosugi T, Terai T, Yamade M, Takayanagi Y, Nishino M, Hamaya Y, Kodaira C, Yamada T, Iwaizumi M, Takagaki K, Yoshida K, Kanaoka S, Ikuma M. Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma. BMC Cancer. 2009 Nov 22;9:408. doi: 10.1186/1471-2407-9-408.

Results Reference

derived

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Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

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