NCT03991104

SOX-based CRT for Esophageal Cancer.

A Phase I/II Study of S-1 and Oxaliplatin Based Definitive Concurrent Chemoradiotherapy (SOX-CRT-01) for Unresectable Locally Advanced Esophageal Cancer.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with esophageal cancer that had locally advanced diseases or with unresectable diseases are being asked to participate in this phase I/II study. This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of IMRT combined with S-1 and Oxaliplatin (SOX) based chemotherapy for unresectable locally advanced esophageal cancer.

Detailed description

Esophageal carcinoma (EC) remains difficult to cure with overall 5-year survival rates for locally advanced stages being poor. Definitive concurrent chemoradiotherapy (dCRT) remains the mainstay of treatment for locally advanced and unresectable EC. Oxaliplatin is a new generation platinum with a more preferable toxicity profile compared to cisplatin. Furthermore, S-1 combines 5-Fu prodrug (tegafur) and two modulators of 5-Fu metabolism, gimeracil (CDHP) and oteracil. Basic studies showed that S-1 has superior anti-cancer effects than 5-Fu and enhances the sensitivity of cancer cells to the effects of radiotherapy. Herein, we designed a prospective phase I/II study, which is combined S-1 and oxaliplatin with IMRT for the patients with locally advanced and unresectable esophageal cancer, and evaluated the tolerability and efficacy of this combination. \<Phase I\> Primary Objective: To establish the safety of combination chemotherapy comprising oxaliplatin (escalating doses: 110, 120, 130 mg/m2, day 1 and day 29), fixed dose of S-1 (80 mg/m2, day1-14 and day 29-42) and IMRT (5040cGy/28fx/5W+) in unresectable locally advanced esophageal cancer. Secondary Objective: To observe the efficacy of this regimen in these patients. \<Phase II\> Primary Objective: To assess the response rate of combination chemotherapy comprising oxaliplatin (recommended dose determined in phase I study, day1 and day29), fixed dose of S-1 (80 mg/m2, day1-14 and day 29-42), and IMRT (5040cGy/28fx/5W+) in unresectable locally advanced esophageal cancer. Secondary Objectives: To determine the adverse reactions of this regimen in these patients. To determine PFS(Progression free survival) of patients treated with this regimen. To determine OS (overall survival) of patients treated with this regimen. To explore the Health-related Quality of life using EORTC QLQ-C30 and EORTC QLQ-OES18 in these patients.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin (3 levels for phase I: 110 mg/m², 120 mg/m² and 130 mg/m²) is administered as a 2 h intravenous infusion in 500 mL of 5% glucose on day 1 and day 29 during the treatment course.
DRUG	S-1 capsule	Patients received a fixed dose of S-1 with a dose of 80 mg/m2/d twice daily for 2 weeks, every 4 weeks.
RADIATION	Intensity modulated radiotherapy (IMRT)	The total radiation dose was set to 50.4 Gy, which was given in 28 fractions of 1.8 Gy once-daily fractions for over 5 weeks.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-12-31
• Completion: 2023-12-31
• First posted: 2019-06-19
• Last updated: 2023-09-21

Locations

1 site across 1 country: China