NCT00021320

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2000

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

May 1, 2000

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

3.7 years

First QC Date

July 11, 2001

Last Update Submit

May 7, 2014

Conditions

Esophageal Cancer

Keywords

stage 0 esophageal cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancersquamous cell carcinoma of the esophagusadenocarcinoma of the esophagus

Interventions

cisplatinDRUG
fluorouracilDRUG
paclitaxelDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction * Potentially resectable disease * No malignant celiac node involvement * No cervical esophageal carcinoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Other: * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant medical or psychiatric illness that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for esophageal cancer Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic radiotherapy Surgery: * See Disease Characteristics * No prior surgical resection of esophageal tumor

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

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

CisplatinFluorouracilPaclitaxelNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCombined Modality TherapyTherapeutics

Study Officials

  • Jonathan Cheng, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

January 1, 2004

Study Completion

April 1, 2009

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

US(1)