Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus

Huai'an First People's Hospital

Status and phase: Unknown; Phase 2

Conditions: Esophagus Squamous Cell Carcinoma

Treatments: Drug: raltitrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT03585530

huaianzhuweiguo1

Details and patient eligibility

About

Concurrent chemoradiotherapy is one of the curative options for esophageal squamous cell carcinoma. We evaluated the efficacy and toxicity of raltitrexed with concurrent radiotherapy in elderly patients with esophageal cancer.

Enrollment: 32 patients

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Histological or cytologic diagnosis of esophageal carcinoma. ECOG performance status 0-1. Age:70-85 years. Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy.

Stage IIa-Ⅳa(AJCC 2002). Target lesions can be measured according to RECIST criteria. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN.

Exclusion criteria

Multiple carcinomas of the esophagus. Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula.

Metastatic disease (M1b). A primary tumor that extended to within 2 cm of the gastroesophageal junction. Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor.

history of a second malignancy other than nonmelanoma skin cancer.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

treatment group

Experimental group

Treatment:

Drug: raltitrexed