Clinical trial NCT01175447: S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
Official title: A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: S-1
radiation
esophageal Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 12
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer
timeFrame: 3 months per patient
Secondary outcomes:
measure: Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).
timeFrame: dependent upon results
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xianghui Du, MD
role: STUDY_CHAIR
References:
citation: Ji Y, Qiu G, Sheng L, Sun X, Zheng Y, Chen M, Du X. A phase I dose escalation study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer. J Thorac Dis. 2016 Mar;8(3):451-8. doi: 10.21037/jtd.2016.02.70.