NCT03910634

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
DRUG	carboplatin	Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: China