NCT00002883

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 1996

Longer than P75 for phase_3

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

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

10.1 years

First QC Date

November 1, 1999

Last Update Submit

February 19, 2021

Conditions

Esophageal CancerGastric Cancer

Keywords

stage I gastric cancerstage II gastric cancerstage I esophageal cancerstage II esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagus

Interventions

cisplatinDRUG
fluorouracilDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age0 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible * Extension to the cardia allowed * Cancer of the cardia with extension to the esophagus or stomach allowed * No in situ cancer of the cardia * No distant metastases PATIENT CHARACTERISTICS: Age: * Not over 75 Performance status: * WHO 0 or 1 Hematopoietic: * WBC at least 4,000 * Polymorphonuclear lymphocytes greater than 2,000 * Platelets at least 100,000 Hepatic: * Not specified Renal: * Creatinine less than 1.3 mg/dL (120 micromoles/L) Cardiovascular: * No prior myocardial infarction * No other cardiac contraindication to surgery Pulmonary: * No respiratory contraindication to surgery Other: * No second malignancy except: * Basal cell carcinoma of the skin * Adequately treated in situ carcinoma of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for tumors of the cardia Endocrine therapy * No prior radiotherapy for tumors of the cardia Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (2)

  • Boige V, Pignon J, Saint-Aubert B, et al.: Final results of a randomized trial comparing preoperative 5-fluorouracil (F)/cisplatin (P) to surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC ACCORD07-FFCD 9703 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4510, 200s, 2007.

    RESULT

  • Ychou M, Pignon JP, Lasser P, et al.: Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-4026, 2006.

    RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

CisplatinFluorouracilChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Marc Ychou, MD, PhD

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1996

Primary Completion

November 1, 2006

Study Completion

August 1, 2010

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

FR(1)