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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Joo-Hang Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yonsei University

Authority:

Unspecified

Study ID:

CDR0000593402

NCT ID:

NCT00659113

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage IIA esophageal cancer
  • stage IIB esophageal cancer
  • stage IIIA esophageal cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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