S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

Zhejiang Provincial People's Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Esophageal Cancer; Radiotherapy; S-1

Treatments: Drug: S-1; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02716688

ZhejiangPPH02

Details and patient eligibility

About

To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Full description

Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cytologically or histologically confirmed esophageal carcinoma;
2. ECOG performance status: 0-1;
3. No treatments prior to enrollment;
4. At least one measurable lesion on CT, MRI or esophageal barium exam;
5. Normal functions of heart, lung, liver, kidney and bone marrow;
6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
7. Informed consent signed.

Exclusion criteria

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Radiotherapy and S-1 arm

Experimental group

Description:

Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.

Treatment:

Radiation: radiotherapy

Drug: S-1