NCT02913066

S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Mianyang Central Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Detailed description

Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy; control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 \~ 42 days, plus cisplatin first 1\~ 4 days and 29 \~ 33 days. Using IMRT radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, or S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle. Primary Outcome Measure is complete remission rate. Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
OTHER	S-1 concurrent radiotherapy	Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~33 planning target volume times, 60\~66 Gray/28\~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1\~ 14 days, 21 days for a cycle.
OTHER	S-1 plus Cisplatin concurrent radiotherapy	Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~30 planning target volume times, Gross tumor volume of primary tumor60\~66 Gray/28\~33), synchronous chemotherapy S-1 70 mg/m2 1\~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1\~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-09-23
• Last updated: 2017-06-16

Locations

1 site across 1 country: China