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Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Docetaxel and Cisplatin
Radiotherapy
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage III esophageal cancer, stage IV esophageal cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer, including the gastroesophageal junction Squamous cell or adenocarcinoma Unresectable disease Meets 1 of the following staging criteria by endoscopic ultrasound: Cervical (supraclavicular) lesion, meeting 1 of the following stages: TX, N+ disease T3-4, NX disease TX, NX, M1a* disease Thoracic (celiac) lesion, meeting 1 of the following stages: Unresectable T4, NX disease TX, NX, M1a* disease Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography No T1-2, N0 disease All tumors encompassable in 1 radiation field No tumor with esophagotracheal fistula PATIENT CHARACTERISTICS: Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST ≤ 1.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine clearance > 60 mL/min Cardiovascular No myocardial infarction within the past 3 months No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No significant arrhythmias No other severe cardiovascular disease Immunologic No uncontrolled active infection No active autoimmune disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment No definite contraindication to corticosteroids No uncontrolled diabetes mellitus No pre-existing peripheral neuropathy > grade 1 No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent No other serious underlying medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy to the chest Other More than 30 days since prior experimental treatment in another clinical trial No other concurrent experimental drugs

Sites / Locations

  • Hirslanden Klinik Aarau
  • Saint Claraspital AG
  • Universitaetsspital-Basel
  • Inselspital Bern
  • Kantonsspital Bruderholz
  • Kantonsspital Graubuenden
  • Kantonsspital
  • Kantonsspital - St. Gallen
  • Regionalspital
  • City Hospital Triemli

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm I

Arm Description

Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

Outcomes

Primary Outcome Measures

Proportion of patients without local failure measured 6 months after completion of study treatment

Secondary Outcome Measures

Adverse reactions measured after completion of study treatment
Successful completion of therapy measured after completion of study treatment
Dysphagia as measured 6 months after completion of study treatment

Full Information

First Posted
October 12, 2005
Last Updated
June 4, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00238407
Brief Title
Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Official Title
Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy. Secondary Determine the feasibility of this regimen in these patients. Determine the adverse reactions of this regimen in these patients. Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen. Determine overall survival of patients treated with this regimen. Determine the long-term survival rate in patients treated with this regimen. Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen. Determine quality of life and clinical benefit in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage III esophageal cancer, stage IV esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Intervention Type
Drug
Intervention Name(s)
Docetaxel and Cisplatin
Intervention Description
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients without local failure measured 6 months after completion of study treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse reactions measured after completion of study treatment
Time Frame
6 months
Title
Successful completion of therapy measured after completion of study treatment
Time Frame
6 months
Title
Dysphagia as measured 6 months after completion of study treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer, including the gastroesophageal junction Squamous cell or adenocarcinoma Unresectable disease Meets 1 of the following staging criteria by endoscopic ultrasound: Cervical (supraclavicular) lesion, meeting 1 of the following stages: TX, N+ disease T3-4, NX disease TX, NX, M1a* disease Thoracic (celiac) lesion, meeting 1 of the following stages: Unresectable T4, NX disease TX, NX, M1a* disease Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography No T1-2, N0 disease All tumors encompassable in 1 radiation field No tumor with esophagotracheal fistula PATIENT CHARACTERISTICS: Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST ≤ 1.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine clearance > 60 mL/min Cardiovascular No myocardial infarction within the past 3 months No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No significant arrhythmias No other severe cardiovascular disease Immunologic No uncontrolled active infection No active autoimmune disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment No definite contraindication to corticosteroids No uncontrolled diabetes mellitus No pre-existing peripheral neuropathy > grade 1 No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent No other serious underlying medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy to the chest Other More than 30 days since prior experimental treatment in another clinical trial No other concurrent experimental drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Razvan Popescu, MD
Organizational Affiliation
Hirslanden Klinik Aarau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Ruhstaller, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hirslanden Klinik Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Saint Claraspital AG
City
Basel
ZIP/Postal Code
CH-4016
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Kantonsspital
City
Liestal
ZIP/Postal Code
CH-4410
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
CH-8063
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20502056
Citation
Ruhstaller T, Templeton A, Ribi K, Schuller JC, Borner M, Thierstein S, von Moos R, Pederiva S, Lohri A, Lombriser N, von Briel C, Koeberle D, Popescu R. Intense therapy in patients with locally advanced esophageal cancer beyond hope for surgical cure: a prospective, multicenter phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 76/02). Onkologie. 2010;33(5):222-8. doi: 10.1159/000305094. Epub 2010 Apr 9.
Results Reference
result

Learn more about this trial

Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery

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