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

NCT03585530 | Unknown Phase 2

• 1 other identifier: huaianzhuweiguo1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Squamous Cell Carcinoma

Keywords

Esophageal neoplasma; adjuvant therapy; raltitrexed; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  From the date of randomization until the date of death

  3 years

Secondary Outcomes (3)

• Disease-free survival (DFS)

  3 years

• treatment-related toxicities

  From the date of randomization until six months after treatment completion

• Quality of life(QOL)

  3 years

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: raltitrexed

Interventions

raltitrexed DRUG

Raltitrexed 2.6mg/m2 was administered on d1、d22

treatment group

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huai'an First People's Hospital: lead

Study Sites (1)

Huai'an First Hospital

Huai'an, Jiangsu, 223300, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

raltitrexed

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 13, 2018
• Study Start: September 5, 2018
• Primary Completion: January 30, 2022
• Study Completion: March 15, 2022
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

CN (1)