Clinical Trial

. 2022 Jul 29;17(1):134.

doi: 10.1186/s13014-022-02099-y.

Dose escalation based on ¹⁸F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Hongcheng Zhu^#^{1

2

3}, Qiufang Liu^#^{2

4}, Hao Xu^#^{1

2

3}, Miao Mo^{2

5}, Zezhou Wang^{2

5}, Kui Lu⁶, Jialiang Zhou⁷, Junqiang Chen⁸, Xiangpeng Zheng⁹, Jinjun Ye¹⁰, Xiaolin Ge¹¹, Honglei Luo¹², Qi Liu^{1

2

3}, Jiaying Deng^{1

2

3}, Dashan Ai^{1

2

3}, Shengnan Hao^{1

2

3}, Junhua Zhang^{1

2

3}, I Hsuan Tseng^{1

2

3}, Shaoli Song^{2

4}, Yun Chen^{13

14

15}, Kuaile Zhao^{16

17

18}

Affiliations

¹ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
² Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
³ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
⁴ Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.
⁵ Department of Cancer Prevention and Statistics, Fudan University Shanghai Cancer Center, Shanghai, China.
⁶ Department of Radiation Oncology, Taizhou Second People's Hospital, Taizhou, Jiangsu, China.
⁷ Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
⁸ Department of Radiation Oncology, Fujian Cancer Hospital, Fuzhou, China.
⁹ Department of Radiation Oncology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
¹⁰ Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China.
¹¹ Department of Radiation Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
¹² Department of Radiation Oncology, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an, Jiangsu, China.
¹³ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁴ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁵ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁶ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. kuaile_z@fudan.edu.cn.
¹⁷ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. kuaile_z@fudan.edu.cn.
¹⁸ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. kuaile_z@fudan.edu.cn.

^# Contributed equally.

PMID: 35906623
PMCID: PMC9338557
DOI: 10.1186/s13014-022-02099-y

Clinical Trial

Dose escalation based on ¹⁸F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Hongcheng Zhu et al. Radiat Oncol. 2022.

. 2022 Jul 29;17(1):134.

doi: 10.1186/s13014-022-02099-y.

Authors

Affiliations

¹ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
² Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
³ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
⁴ Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.
⁵ Department of Cancer Prevention and Statistics, Fudan University Shanghai Cancer Center, Shanghai, China.
⁶ Department of Radiation Oncology, Taizhou Second People's Hospital, Taizhou, Jiangsu, China.
⁷ Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
⁸ Department of Radiation Oncology, Fujian Cancer Hospital, Fuzhou, China.
⁹ Department of Radiation Oncology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
¹⁰ Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China.
¹¹ Department of Radiation Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
¹² Department of Radiation Oncology, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an, Jiangsu, China.
¹³ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁴ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁵ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. chenyun_qz@fudan.edu.cn.
¹⁶ Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. kuaile_z@fudan.edu.cn.
¹⁷ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. kuaile_z@fudan.edu.cn.
¹⁸ Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. kuaile_z@fudan.edu.cn.

^# Contributed equally.

PMID: 35906623
PMCID: PMC9338557
DOI: 10.1186/s13014-022-02099-y

Abstract

Introduction: Definitive chemoradiotherapy has established the standard non-surgical treatment for locally advanced esophageal cancer. The standard dose of 50-50.4 Gy has been established decades ago and been confirmed in modern trials. The theorical advantage of better local control and technical advances for less toxicity have encouraged clinicians for dose escalation investigation. ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography/computed tomography (PET/CT) have the potential to tailor therapy for esophageal patients not showing response to CRT and pioneers the PET-based dose escalation.

Methods and analysis: The ESO-Shanghai 12 trial is a prospective multicenter randomized phase 3 study in which patients are randomized to either 61.2 Gy or 50.4 Gy of radiation dose by PET response. Both groups undergo concurrent chemoradiotherapy with paclitaxel/cisplatin regimen for 2 cycles followed by consolidation chemotherapy for 2 cycles. Patients with histologically confirmed ESCC [T1N1-3M0, T2-4NxM0, TxNxM1 (Supraclavicular lymph node metastasis only), (AJCC Cancer Staging Manual, 8th Edition)] and without any prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer will be eligible. The primary endpoints included overall survival in PET/CT non-responders (SUV_max > 4.0) and overall survival in total population. Patients will be stratified by standardized uptake volume, gross tumor volume and tumor location. The enrollment could be ended, when the number of PET/CT non-responder reached 132 and the total population reached 646 for randomization.

Ethics and dissemination: This trial has been approved by the Fudan University Shanghai Cancer Center Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations. Trial registration The trial was initiated in 2018 and is currently recruiting patients. Trial registration number NCT03790553.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no financial or non-financial competing interests.

Figures

**Fig. 1**
Trial diagram of the ESO-Shanghai 12 trial. PET = Positron emission tomography; SUV = Standard uptake value; GTV = Gross tumor volume; PTX = Paclitaxel; DDP = Cisplatin

**Fig. 2**
Treatment design of the ESO-Shanghai 12 trial. PET = Positron emission tomography; SUV = Standard uptake value; R = Randomization; RT = Radiation therapy; TP = Paclitaxel + Cisplatin; W = Week

See this image and copyright information in PMC

References

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Dose escalation based on ¹⁸F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Affiliations

Dose escalation based on ¹⁸F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials