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

NCT ID: NCT00238407

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2010-08-31

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Docetaxel and Cisplatin

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: DRUG

Radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Razvan Popescu, MD

Role: STUDY_CHAIR

Hirslanden Klinik Aarau

Thomas Ruhstaller, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital of St. Gallen

Locations

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

Sankt Gallen, , Switzerland

Regionalspital

Thun, , Switzerland

City Hospital Triemli

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 20502056 (View on PubMed)

Other Identifiers

EU-20529

Identifier Type: -

Identifier Source: secondary_id

SAKK 76/02

Identifier Type: -

Identifier Source: org_study_id