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

This study has been terminated.
(difficulty in recruitment)
Sponsor:
Information provided by:
Ministry of Scientific Research and Information Technology, Poland
ClinicalTrials.gov Identifier:
NCT00559351
First received: November 15, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Esophageal Neoplasms
Squamous Cell Cancer
Procedure: transthoracic esophagectomy 2-field extended lymphadenectomy
Drug: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)
Radiation: neoadjuvant chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.

Resource links provided by NLM:


Further study details as provided by Ministry of Scientific Research and Information Technology, Poland:

Primary Outcome Measures:
  • mean, median, 1-year, 3-year, 5-year overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • toxicity-related morbidity and mortality [ Time Frame: 30-day ]
  • postoperative morbidity and mortality [ Time Frame: 30-day ]
  • clinical and pathological response rates [ Time Frame: 60-day ]
  • curative resection rate [ Time Frame: 30-day ]

Enrollment: 84
Study Start Date: December 2001
Study Completion Date: April 2004
Arms Assigned Interventions
Active Comparator: S
esophagectomy
Procedure: 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
Experimental: CHTS
neoadjuvant chemotherapy followed by esophagectomy
Drug: 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
Experimental: CHRTS
neoadjuvant chemoradiotherapy followed by esophagectomy
Radiation: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559351

Locations
Poland
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
Lublin, Lubelskie, Poland, 20-081
Sponsors and Collaborators
Ministry of Scientific Research and Information Technology, Poland
Investigators
Principal Investigator: Grzegorz Wallner, MD, PhD 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559351     History of Changes
Other Study ID Numbers: 6P05C01320, PL SCSR 6P05C01320
Study First Received: November 15, 2007
Last Updated: November 15, 2007
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Ministry of Scientific Research and Information Technology, Poland:
esophagectomy
chemotherapy
chemoradiotherapy
combined modality therapy

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014