A Phase 2 interventional study of Paclitaxel and Cisplatin in Neoplasm, Esophageal and Squamous Cell Carcinoma, sponsored by Mian XI. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Mian XI · Phase 2, Interventional, and Treatment
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).
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 216 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
Patients with baseline PET scan assigned to this Arm will receive two cycles of 3-weekly schedule of induction chemotherapy with paclitaxel/cisplatin (TP), consisting of paclitaxel 150 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. 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 FOLFOX 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.
Drug: Paclitaxel · Drug: Cisplatin · Radiation: Intensity-modulated radiotherapy · Device: PET
Patients with baseline PET scan assigned to this Arm will receive three cycles of 2-weekly schedule of induction chemotherapy with FOLFOX (oxaliplatin, leucovorin, 5-FU), consisting of oxaliplatin 85 mg/m2 on day 1, leucovorin 400 mg/m2, and 5-FU 2 g/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. 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 TP 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.
Drug: Oxaliplatin · Drug: 5-FU · Drug: Leucovorin · Radiation: Intensity-modulated radiotherapy · Device: PET
chemotherapy drug
Also known as: Taxol
chemotherapy drug
Also known as: DDP
chemotherapy drug
Also known as: OXA
chemotherapy drug
Also known as: Fluorouracil
chemotherapy drug
Also known as: CF
radiotherapy technique
Also known as: IMRT
Using PET to evaluate response to induction chemotherapy
Also known as: PET-CT
clinical complete response
RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies.
Time frame: 3 months after the treatment (plus or minus 7 days)
Overall survival
From the enrollment to the date of death from any cause or date of lost follow-up
Time frame: 3 years after randomization
Progression-free survival
From the date of randomization to the date of disease progression or last follow-up
Time frame: 3 years after randomization
Chemoradiotherapy-related toxicity
Treatment-related toxicity
Time frame: From the date of randomization to the 3 months after treatment
Plan to share: No
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Mian XI