IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients

April 9, 2019 updated by: Zhu Yujia, Sun Yat-sen University

IMRT Combined With Carboplatin Versus IMRT Combined With Carboplatin and Fluorouracil in the Treatment of Locally Advanced Esophageal Cancer in Elderly Patients With High Risk of Chemotherapy: a Randomized Controlled Clinical Study

An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • SYSU Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age (> 65 years)
  • Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons.
  • PS score < 2, Chemotherapy risk score is medium and high risk
  • No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past.
  • Diseases measurable according to RECIST standards
  • Hematological examination requires Hb (>90g/L), ANC (>2.0 *109/L) and platelet (>100 *109/L). Serum albumin (>3.0g/dL)
  • Serum creatinine < 1.25 times normal upper limit (UNL), or creatinine clearance rate (>60 ml/min). Total bilirubin < upper limit of normal value
  • Total bilirubin < the upper limit of normal value, AST (SGOT) and ALT (SGPT) < 2.5 times the upper limit of normal value, ALP < 2.5 times the upper limit of normal value (ULN)
  • If exploratory surgery is performed, the patient will recover at least 2 weeks after operation.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients with fertility without adequate contraceptive measures.
  • Anaphylaxis to 5FU and carboplatin is known.
  • Anaphylaxis known to exist with any drug in the study
  • Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated.
  • Discovery of esophageal fistula or risk of esophageal bleeding before treatment
  • Distant organ metastasis is known
  • Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (> grade 2).
  • Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred.
  • Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.)
  • Gastrointestinal bleeding requires frequent blood transfusion.
  • It is known to carry human immunodeficiency virus (HIV) or AIDS.
  • Suffering from mental illness
  • The known neuropathy is of grade 2 or higher severity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT combined with carboplatin
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
Radiation: Intensity modulated radiation therapy
Radiotherapy for 5-6 weeks，50-60Gy
Other Names:
  • IMRT
Drug: carboplatin
Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
Placebo Comparator: IMRT combined with carboplatin and fluorouracil
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
Radiation: Intensity modulated radiation therapy
Radiotherapy for 5-6 weeks，50-60Gy
Other Names:
  • IMRT
Drug: carboplatin
Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
Drug: Fluorouracil
1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
Other Names:
  • 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall objective response rate
Time Frame: up to 24 months
The proportion of partial and complete remission of tumors
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of toxic and side effects above 3 degrees
Time Frame: up to 24 months
The Incidence of toxic and side effects above 3 degrees in overall patients
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Yonghong Hu, Doctor, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 9, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GD-Q201807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe