NCT00578201

Brief Summary

This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

Typical duration 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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 31, 2011

Status Verified

May 1, 2007

Enrollment Period

3.3 years

First QC Date

December 20, 2007

Last Update Submit

March 30, 2011

Conditions

Esophageal Cancer Stage III

Keywords

Esophageal neoplasmsCetuximabOxaliplatinFluorouracilradiotherapy

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR) at 12 weeks with radiochemotherapy (first evaluation), and if applicable, within 2 to 4 weeks following the end of additional treatment with the combination Cetuximab-FOLFOX (second evaluation)

    at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment

Secondary Outcomes (1)

  • Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen

    during the study

Study Arms (1)

1

EXPERIMENTAL

radiochemotherapy,combination Cetuximab-FOLFOX

Drug: radiochemotherapy,combination Cetuximab-FOLFOX

Interventions

radiochemotherapy,combination Cetuximab-FOLFOXDRUG

objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Also known as: objective response rate,combination Cetuximab-FOLFOX
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed squamous cell carcinoma of the esophagus stage III (according to UICC classification)
  • Measurable disease according to the RECIST criteria
  • WHO performance status of 0 or 1
  • Age 18-80 years old
  • Reference imaging within the 2 weeks prior to the treatment
  • Hematological and biochemical assessment within the 2 weeks prior to the treatment
  • Neutrophils \>1.5 10 9/L, platelets \>150.10 9/L, Haemoglobin ≥10g/dL, Bilirubin ≤ 1.25 ULN, Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 ULN Woman of childbearing potential must use effective contraception methods Written informed consent obtained No prior chemotherapy or radiation therapy for esophageal cancer

You may not qualify if:

  • Stage I, II or IV (according to UICC classification)
  • Esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor
  • visceral metastasis
  • orotracheal fistula weight loss \>15% within the previous 6 months Pregnancy or breast feeding Contra indication to the study treatment History of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months
  • Peripheral Neuropathy NCI \>1
  • Liver Failure
  • Prior thoracic radiation therapy
  • history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus Esophageal Endoprosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint Jean

Lyon, 69008, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Gérard LLEDO, MD

    Assistance Publique - Hôpitaux de Paris

    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

December 20, 2007

First Posted

December 21, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 31, 2011

Record last verified: 2007-05

Locations

FR(1)