Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: Docetaxel and Cisplatin Radiation: Radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Proportion of patients without local failure measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adverse reactions measured after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Successful completion of therapy measured after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Dysphagia as measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | March 2004 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Switzerland | |
| Hirslanden Klinik Aarau | |
| Aarau, Switzerland, CH-5001 | |
| Saint Claraspital AG | |
| Basel, Switzerland, CH-4016 | |
| Universitaetsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonsspital Bruderholz | |
| Bruderholz, Switzerland, CH-4101 | |
| Kantonsspital Graubuenden | |
| Chur, Switzerland, CH-7000 | |
| Kantonsspital | |
| Liestal, Switzerland, CH-4410 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Regionalspital | |
| Thun, Switzerland, 3600 | |
| City Hospital Triemli | |
| Zurich, Switzerland, CH-8063 | |
| Study Chair: | Razvan Popescu, MD | Hirslanden Klinik Aarau |
| Principal Investigator: | Thomas Ruhstaller, MD | Kantonsspital St. Gallen |
More Information
Publications:
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00238407 History of Changes |
| Other Study ID Numbers: | SAKK 76/02, EU-20529 |
| Study First Received: | October 12, 2005 |
| Last Updated: | June 4, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage III esophageal cancer stage IV esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013