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

Sponsor

Huai'an First People's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03585530

Collaborator

(none)

Enrollment

Location

Arm

42.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophagus Squamous Cell Carcinoma	Drug: raltitrexed	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 5, 2018

Anticipated Primary Completion Date :

Jan 30, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group	Drug: raltitrexed Raltitrexed 2.6mg/m2 was administered on d1、d22

Arm

Intervention/Treatment

Experimental: treatment group

Drug: raltitrexed

Raltitrexed 2.6mg/m2 was administered on d1、d22

Outcome Measures

Primary Outcome Measures

Overall survival(OS) [3 years]
From the date of randomization until the date of death

Secondary Outcome Measures

Disease-free survival (DFS) [3 years]
From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause
treatment-related toxicities [From the date of randomization until six months after treatment completion]
Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0
Quality of life(QOL) [3 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.