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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Razvan Popescu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hirslanden Klinik Aarau

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 76/02

NCT ID:

NCT00238407

Start Date:

March 2004

Completion Date:

August 2010

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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