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RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

NCT ID: NCT00559351

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.

Conditions

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Esophageal Neoplasms Squamous Cell Cancer

Keywords

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esophagectomy chemotherapy chemoradiotherapy combined modality therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S

esophagectomy

Group Type ACTIVE_COMPARATOR

transthoracic esophagectomy 2-field extended lymphadenectomy

Intervention Type PROCEDURE

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

CHTS

neoadjuvant chemotherapy followed by esophagectomy

Group Type EXPERIMENTAL

neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)

Intervention Type 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

CHRTS

neoadjuvant chemoradiotherapy followed by esophagectomy

Group Type EXPERIMENTAL

neoadjuvant chemoradiotherapy

Intervention Type RADIATION

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

Interventions

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transthoracic esophagectomy 2-field extended lymphadenectomy

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

Intervention Type PROCEDURE

neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)

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

Intervention Type DRUG

neoadjuvant chemoradiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Scientific Research and Information Technology, Poland

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Grzegorz Wallner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Lublin, Lublin Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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PL SCSR 6P05C01320

Identifier Type: -

Identifier Source: secondary_id

6P05C01320

Identifier Type: -

Identifier Source: org_study_id