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A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer


Phase 1
70 Years
85 Years
Not Enrolling
Both
Esophageal Cancer

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Trial Information

A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer


Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase
II study when administered concurrently with thoracic radiation in elderly patients (>70
years old) with esophageal Cancer.

Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and
80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times
weekly to a total dose of 54 Gy.


Inclusion Criteria:



- Histologically documented diagnosis of esophageal Cancer

- Disease must be encompassed in a radiotherapy field.Patients with celiac,
perigastric, mediastinal or supraclavicular adenopathy are eligible

- age:70-85 years

- Written informed consent.

- Performance status of 0 to 2

- Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th
power/L.

- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN)
Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5
times ULN (or less than or equal to 5 times ULN in case of known liver involvement

- Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

Exclusion Criteria:

- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible).

- Prior systemic chemotherapy or radiation therapy for esophageal cancer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer

Outcome Description:

the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.

Outcome Time Frame:

3 months per patient

Safety Issue:

Yes

Principal Investigator

Xianghui Du, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH07

NCT ID:

NCT01175447

Start Date:

February 2010

Completion Date:

December 2011

Related Keywords:

  • Esophageal Cancer
  • S-1
  • radiation
  • esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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