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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03585530
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Huai'an First People's Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : September 5, 2018
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
    From the date of randomization until the date of death

Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 3 years ]
    From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause

  2. treatment-related toxicities [ Time Frame: 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

  3. Quality of life(QOL) [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03585530

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Contact: wei-guo Zhu, MD +861351155000

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China, Jiangsu
Huai'an First Hospital Recruiting
Huai'an, Jiangsu, China, 223300
Contact: wei-guo zhu, MD         
Sponsors and Collaborators
Huai'an First People's Hospital

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Responsible Party: Huai'an First People's Hospital Identifier: NCT03585530     History of Changes
Other Study ID Numbers: huaianzhuweiguo1
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huai'an First People's Hospital:
Esophageal neoplasma
adjuvant therapy

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors