RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
Primary Purpose
Esophageal Neoplasms, Squamous Cell Cancer
Status
Terminated
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
transthoracic esophagectomy 2-field extended lymphadenectomy
neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)
neoadjuvant chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms focused on measuring esophagectomy, chemotherapy, chemoradiotherapy, combined modality therapy
Eligibility 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.
Sites / Locations
- 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
S
CHTS
CHRTS
Arm Description
esophagectomy
neoadjuvant chemotherapy followed by esophagectomy
neoadjuvant chemoradiotherapy followed by esophagectomy
Outcomes
Primary Outcome Measures
mean, median, 1-year, 3-year, 5-year overall survival
Secondary Outcome Measures
toxicity-related morbidity and mortality
postoperative morbidity and mortality
clinical and pathological response rates
curative resection rate
Full Information
NCT ID
NCT00559351
First Posted
November 15, 2007
Last Updated
November 15, 2007
Sponsor
Ministry of Scientific Research and Information Technology, Poland
1. Study Identification
Unique Protocol Identification Number
NCT00559351
Brief Title
RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruitment
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ministry of Scientific Research and Information Technology, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Squamous Cell Cancer
Keywords
esophagectomy, chemotherapy, chemoradiotherapy, combined modality therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S
Arm Type
Active Comparator
Arm Description
esophagectomy
Arm Title
CHTS
Arm Type
Experimental
Arm Description
neoadjuvant chemotherapy followed by esophagectomy
Arm Title
CHRTS
Arm Type
Experimental
Arm Description
neoadjuvant chemoradiotherapy followed by esophagectomy
Intervention Type
Procedure
Intervention Name(s)
transthoracic esophagectomy 2-field extended lymphadenectomy
Intervention Description
right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck
Intervention Type
Drug
Intervention Name(s)
neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)
Intervention Description
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
Radiation
Intervention Name(s)
neoadjuvant chemoradiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
mean, median, 1-year, 3-year, 5-year overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
toxicity-related morbidity and mortality
Time Frame
30-day
Title
postoperative morbidity and mortality
Time Frame
30-day
Title
clinical and pathological response rates
Time Frame
60-day
Title
curative resection rate
Time Frame
30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grzegorz Wallner, MD, PhD
Organizational Affiliation
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
We'll reach out to this number within 24 hrs