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

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00238407

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.1

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Docetaxel and Cisplatin Radiation: Radiotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I 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.	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.

Arm

Intervention/Treatment

Active Comparator: Arm I

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hirslanden Klinik Aarau	Aarau	Switzerland	CH-5001
2	Saint Claraspital AG	Basel	Switzerland	CH-4016
3	Universitaetsspital-Basel	Basel	Switzerland	CH-4031
4	Inselspital Bern	Bern	Switzerland	CH-3010
5	Kantonsspital Bruderholz	Bruderholz	Switzerland	CH-4101
6	Kantonsspital Graubuenden	Chur	Switzerland	CH-7000
7	Kantonsspital	Liestal	Switzerland	CH-4410
8	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007
9	Regionalspital	Thun	Switzerland	3600
10	City Hospital Triemli	Zurich	Switzerland	CH-8063