NCT00197444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Last Update Submit

February 19, 2009

Conditions

Esophageal CancerSquamous Cell Carcinoma

Keywords

esophageal cancerNedaplatin5-FUchemotherapyradiationchemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Response rate

    3 months

Secondary Outcomes (2)

  • Adverse events

    every 3-6 months

  • Survival rate

    every 3-6 months

Study Arms (1)

1

EXPERIMENTAL

Chemoradiotherapy

Drug: CDGP/5-FU combined with radiationRadiation: Radiotherapy

Interventions

CDGP/5-FU combined with radiationDRUG

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.

Also known as: Nedaplatin, 5-FU
1
RadiotherapyRADIATION

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.

Also known as: Radiation
1

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • serious cardiac disease
  • prior chemotherapy and radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Medicine, Hamamatsu University School of Medicine

Hamamatsu, 431-3192, Japan

Location

Related Publications (1)

  • 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.

    PMID: 19930599DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsCarcinoma, Squamous Cell

Interventions

RadiationnedaplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Physical PhenomenaUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Satoshi Osawa, M.D.

    First Department of Medicine, Hamamatsu University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

JP(1)