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

Phase 2

• Conditions: Esophageal Cancer; Radiotherapy Side Effect
• Interventions: Radiation: Intensity modulated radiation therapy; Drug: Fluorouracil; Drug: carboplatin

• Registration Number: NCT03910634
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study Start: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMRT combined with carboplatin	Intensity modulated radiation therapy	Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
IMRT combined with carboplatin and fluorouracil	Intensity modulated radiation therapy	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
IMRT combined with carboplatin and fluorouracil	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
IMRT combined with carboplatin	carboplatin	Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
IMRT combined with carboplatin and fluorouracil	carboplatin	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

Primary Outcome Measures

Name	Time	Method
Overall objective response rate	up to 24 months	The proportion of partial and complete remission of tumors

Secondary Outcome Measures

Name	Time	Method
Incidence of toxic and side effects above 3 degrees	up to 24 months	The Incidence of toxic and side effects above 3 degrees in overall patients

Trial Locations

Locations (1)

SYSU Cancer Center; 🇨🇳 Guangzhou, Guangdong, China