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

NCT ID: NCT03910634

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-09
• Study Completion Date: 2021-12-31

Brief Summary

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

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.

Conditions

Esophageal Cancer; Radiotherapy Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IMRT combined with carboplatin

Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Group Type: EXPERIMENTAL

Intensity modulated radiation therapy

Intervention Type: RADIATION

Radiotherapy for 5-6 weeks，50-60Gy

carboplatin

Intervention Type: DRUG

Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

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

Group Type: PLACEBO_COMPARATOR

Fluorouracil

Intervention Type: DRUG

1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks

Intensity modulated radiation therapy

Intervention Type: RADIATION

Radiotherapy for 5-6 weeks，50-60Gy

carboplatin

Intervention Type: DRUG

Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Interventions

Fluorouracil

1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks

Intervention Type: DRUG

Intensity modulated radiation therapy

Radiotherapy for 5-6 weeks，50-60Gy

Intervention Type: RADIATION

carboplatin

Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Intervention Type: DRUG

Other Intervention Names

5-FU; IMRT

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhu Yujia

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yonghong Hu, Doctor

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

SYSU Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GD-Q201807

Identifier Type: -

Identifier Source: org_study_id