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

NCT00238407 | Completed Phase 2 DMC

• 2 other identifiers: SAKK 76/02EU-20529
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 10

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.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage III esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Arm I

ACTIVE COMPARATOR

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; Radiation: Radiotherapy

Interventions

Docetaxel and Cisplatin 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.

Arm I

Radiotherapy RADIATION

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

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (10)

Hirslanden Klinik Aarau

Aarau, CH-5001, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Kantonsspital

Liestal, CH-4410, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

Related 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 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.

  PMID: 20502056 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Docetaxel; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Razvan Popescu, MD

  Hirslanden Klinik Aarau

  STUDY CHAIR

• Thomas Ruhstaller, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: March 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: August 1, 2010
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CH (10)