Know Cancer

forgot password

Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Phase 1
18 Years
70 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in
combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal

Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a
total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days
1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1
was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this

Inclusion Criteria:

- Histologic proof of primary squamous cell or adenocarcinoma of the esophagus

- Locoregionally advanced carcinoma of esophagus without systemic metastases

- Zubrod Performance Status 0-1;

- Patients ≥ 18 years of age;

- No hypersensitivity to E. coli −derived products;

- AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl
and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;

- Patients with prior malignancy are eligible if curable non-melanoma skin cancer or
cervical cancer in situ or disease free ≥ 5 years;

- No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within
the past 5 years; no prior esophageal or gastric surgery;

- Written informed consent.

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:


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 nedaplatin and thoracic radiotherapy

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:


Principal Investigator

Xianghui Du, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Zhejiang Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

January 2011

Related Keywords:

  • Esophageal Cancer
  • esophageal Cancer
  • radiation
  • s-1
  • nedaplatin
  • Esophageal Diseases
  • Esophageal Neoplasms