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

Primary Purpose

Esophagus Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

raltitrexed

About this trial

This is an interventional treatment trial for Esophagus Squamous Cell Carcinoma focused on measuring Esophageal neoplasma, adjuvant therapy, raltitrexed, radiotherapy

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

Huai'an First Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

Outcomes

Primary Outcome Measures

Overall survival(OS)

From the date of randomization until the date of death

Secondary Outcome Measures

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

treatment-related toxicities

Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

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)

Full Information

NCT ID

NCT03585530

First Posted

July 1, 2018

Last Updated

April 5, 2021

Sponsor

Huai'an First People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03585530

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

January 30, 2022 (Anticipated)

Study Completion Date

March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Huai'an First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagus Squamous Cell Carcinoma

Keywords

Esophageal neoplasma, adjuvant therapy, raltitrexed, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

raltitrexed

Intervention Description

Raltitrexed 2.6mg/m2 was administered on d1、d22

Primary Outcome Measure Information:

Title

Overall survival(OS)

Description

From the date of randomization until the date of death

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease-free survival (DFS)

Description

From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause

Time Frame

3 years

Title

treatment-related toxicities

Description

Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

Time Frame

From the date of randomization until six months after treatment completion

Title

Quality of life(QOL)

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Huai'an First Hospital

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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