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

Esophageal Cancer Clinical Trial

Official title:

Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238407
• Other study ID #: SAKK 76/02
• Secondary ID: EU-20529
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: June 4, 2012
• Start date: March 2004
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Docetaxel and Cisplatin
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.

Radiation:
• Radiotherapy
Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

Locations

Country	Name	City	State
Switzerland	Hirslanden Klinik Aarau	Aarau
Switzerland	Saint Claraspital AG	Basel
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital Bruderholz	Bruderholz
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Kantonsspital	Liestal
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	Regionalspital	Thun
Switzerland	City Hospital Triemli	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients without local failure measured 6 months after completion of study treatment		6 months	No
Secondary	Adverse reactions measured after completion of study treatment		6 months	Yes
Secondary	Successful completion of therapy measured after completion of study treatment		6 months	No
Secondary	Dysphagia as measured 6 months after completion of study treatment		6 months	No