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Esophageal CancerPhase 2NCT00238407

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

A Phase 2 study testing Docetaxel and Cisplatin and Radiotherapy in people with Esophageal Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Docetaxel and Cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
10 sitesSwitzerland
Study dates
Mar 2004to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Switzerland10 sites

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Kantonsspital

    Liestal, CH-4410

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • City Hospital Triemli

    Zurich, CH-8063

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Docetaxel and Cisplatin, Radiotherapy
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage III esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel and CisplatinDrug

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

  • RadiotherapyRadiation

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

Study groups in NCT00238407
Study groupRoleWhat they receive
Arm IActive comparatorPatients 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.
Receives: Drug: Docetaxel and Cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (3)

  1. Adverse reactions measured after completion of study treatment

    Measured: 6 months

  2. Successful completion of therapy measured after completion of study treatment

    Measured: 6 months

  3. Dysphagia as measured 6 months after completion of study treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2005 (estimated)
  2. Study startMar 2004
  3. Primary completionFeb 2008
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238407
Sponsor's protocol ID
SAKK 76/02
Other IDs
EU-20529
Status last verified
Jun 2012
First submitted
12 Oct 2005
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20502056

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Cisplatin and Radiotherapy in people with Esophageal Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients without local failure measured 6 months after completion of study treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00238407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.

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