NCT03791905

PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Mian XI · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).

Detailed description

A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.

Conditions

• Neoplasm, Esophageal
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	chemotherapy drug
DRUG	Cisplatin	chemotherapy drug
DRUG	Oxaliplatin	chemotherapy drug
DRUG	5-FU	chemotherapy drug
DRUG	Leucovorin	chemotherapy drug
RADIATION	Intensity-modulated radiotherapy	radiotherapy technique
DEVICE	PET	Using PET to evaluate response to induction chemotherapy

Timeline

• Start date: 2019-01-15
• Primary completion: 2021-07-01
• Completion: 2023-12-01
• First posted: 2019-01-03
• Last updated: 2021-03-23

Locations

1 site across 1 country: China