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

Esophagus Squamous Cell Carcinoma Clinical Trial

Official title:

Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Phase-II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03585530
• Other study ID #: huaianzhuweiguo1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 5, 2018
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2021
• Source: Huai'an First People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: March 15, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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-?a(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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Esophagus Squamous Cell Carcinoma

Intervention

Drug:
• raltitrexed
Raltitrexed 2.6mg/m2 was administered on d1?d22

Locations

Country	Name	City	State
China	Huai'an First Hospital	Huai'an	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Huai'an First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival(OS)	From the date of randomization until the date of death	3 years
Secondary	Disease-free survival (DFS)	From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause	3 years
Secondary	treatment-related toxicities	Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0	From the date of randomization until six months after treatment completion
Secondary	Quality of life(QOL)	QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after treatment among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30)	3 years