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AzTrials

Esophageal CancerPhase 2NCT00659113

S-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IVA Esophageal Cancer That Can Be Removed by Surgery

A Phase 2 study testing cisplatin, tegafur-gimeracil-oteracil potassium and cytology specimen collection procedure in people with Esophageal Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as S-1 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 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cisplatin, tegafur-gimeracil-oteracil potassium and cytology specimen collection procedure
Type of treatment
Surgery or procedure
How many people
32 participants
Where
1 siteSouth Korea
Study dates
Mar 2008to not given
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the esophagus
  • Stage IIA-IVA disease
  • Resectable disease
  • Measurable disease, defined as at least 1 measurable lesion by RECIST criteria
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/uL
  • Hemoglobin ≥ 9.0 g/dL (transfusion correction allowed)
  • Platelets ≥ 100,000/uL
  • Creatinine < 1.5 mg/dL
  • Total bilirubin < 2 times upper limit of normal (ULN)
  • ALT/AST < 3 times ULN
  • Fertile patients must use effective contraception
  • Not pregnant or nursing
  • Able to take oral medication
  • No active peptic ulcer disease
  • No known hypersensitivity to study drugs
  • No serious uncontrolled systemic intercurrent illness, including the following:
  • Poorly controlled diabetes
  • Active infection
  • No history of significant neurological or mental disorder, including seizures or dementia
  • No malignancy within the past 5 years, except carcinoma in situ of the cervix, or nonmelanomatous carcinoma of the skin
  • No active cardiac disease uncontrolled by therapy
  • No myocardial infarction within the past 12 months
  • No interstitial lung disease or extended fibrosis of lung

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for esophageal cancer
  • No prior surgical procedure affecting absorption
  • No concurrent flucytosine or other fluoropyrimidine-group anticancer drugs
  • No concurrent systemic chemotherapy, investigational drug, or radiotherapy

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Yonsei Cancer Center at Yonsei University Medical Center

    Seoul, 120-752

    Joo-Hang Kim, MD, 82-2-2228-8131, kjhang@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 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. Giving radiation therapy together with more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with radiation therapy works in treating patients with stage IIA, stage III, or stage IVA esophageal cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy.

Secondary

  • To evaluate overall survival of these patients.
  • To evaluate progression-free survival of these patients.
  • To evaluate toxicity in these patients.
  • To correlate initial squamous cell carcinoma antigen and C-reactive protein with response and survival in these patients.

OUTLINE: Patients receive oral S-1 twice weekly, cisplatin IV over 2 hours on day 1, and undergo radiotherapy 5 days a week in weeks 1 and 2. Treatment repeats every 3 weeks for 2 courses.

Tumor tissue samples are collected by esophagoscopy with biopsy and brushings for analysis of initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival.

After completion of study treatment, patients are followed for 6 months.

Being tested
cisplatin, tegafur-gimeracil-oteracil potassium, cytology specimen collection procedure, endoscopic biopsy
Keywords
stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • cisplatinDrug

  • tegafur-gimeracil-oteracil potassiumDrug

  • cytology specimen collection procedureOther

  • endoscopic biopsyProcedure or surgery

What is being measured

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

  1. Response rate

Secondary outcomes (4)

  1. Overall survival

  2. Progression-free survival

  3. Toxicity

  4. Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival

Timeline

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

  1. First posted16 Apr 2008 (estimated)
  2. Study startMar 2008

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
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00659113
Sponsor's protocol ID
CDR0000593402
Other IDs
YONSEI-4-2007-0342
Status last verified
Dec 2008
First submitted
15 Apr 2008
Last updated
6 Dec 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, tegafur-gimeracil-oteracil potassium and cytology specimen collection procedure in people with Esophageal Cancer, run by Yonsei University at 1 site in South Korea.

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: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate. 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 NCT00659113.

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 6 Dec 2011.

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