NCT00559351

Brief Summary

The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

Trial Health

57
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Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
Last Updated

November 16, 2007

Status Verified

September 1, 2007

First QC Date

November 15, 2007

Last Update Submit

November 15, 2007

Conditions

Esophageal NeoplasmsSquamous Cell Cancer

Keywords

esophagectomychemotherapychemoradiotherapycombined modality therapy

Outcome Measures

Primary Outcomes (1)

  • mean, median, 1-year, 3-year, 5-year overall survival

    5 years

Secondary Outcomes (4)

  • toxicity-related morbidity and mortality

    30-day

  • postoperative morbidity and mortality

    30-day

  • clinical and pathological response rates

    60-day

  • curative resection rate

    30-day

Study Arms (3)

S

ACTIVE COMPARATOR

esophagectomy

Procedure: transthoracic esophagectomy 2-field extended lymphadenectomy

CHTS

EXPERIMENTAL

neoadjuvant chemotherapy followed by esophagectomy

Drug: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)

CHRTS

EXPERIMENTAL

neoadjuvant chemoradiotherapy followed by esophagectomy

Radiation: neoadjuvant chemoradiotherapy

Interventions

transthoracic esophagectomy 2-field extended lymphadenectomyPROCEDURE

right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck

S
neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)DRUG

21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval

CHTS
neoadjuvant chemoradiotherapyRADIATION

21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval

CHRTS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
  • Patients' age above 18 years
  • General condition with Karnofsky performance status of \>70
  • Circulatory and pulmonary capacity at normal range (FEV1 \>60%; FVC \>60%, NYHA I-II, cardiac output \>40%)
  • Normal function of the bone marrow (RBC \>3,5 T/l; PLT \>100 G/l)
  • Normal renal (creatinine \<1.5 of the upper limit) and liver (AST or ALT \<2,5 of the upper limit or bilirubin \<1,5 of the upper limit) function

You may not qualify if:

  • Metastatic disease
  • Synchronous malignancy
  • History of other cancer within 5 years prior to esophageal cancer treatment
  • History of allergic reaction to cisplatin of 5-fluorouracil
  • Systemic infection
  • Pregnancy or female patients in childbearing age without proper contraceptives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland

Lublin, Lublin Voivodeship, 20-081, Poland

Location

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms, Squamous Cell

Interventions

Neoadjuvant TherapyCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Grzegorz Wallner, MD, PhD

    2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

December 1, 2001

Study Completion

April 1, 2004

Last Updated

November 16, 2007

Record last verified: 2007-09

Locations

PL(1)