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RecruitingNCT03790553Updated Aug 3, 2023

Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

A Phase 3 interventional study of Radiotherapy in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2018; still recruiting 7 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
646
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma

Keywords

  • chemoradiotherapy
  • esophageal cancer
  • PET/CT
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 646 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75 years; both genders
  • Esophageal squamous cell carcinoma confirmed by pathology.
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
  • Use of an effective contraceptive for adults to prevent pregnancy.
  • No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
  • WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT \< 2·5 * ULN, TBIL \< 1·5 * ULN, and Creatinine \< 1·5 *ULN.
  • ECOG 0-2.
  • Life expectancy of more than 3 months.
  • Agreement of PET/CT accessment at 25-28 radiotherapy fraction.

Exclusion criteria

Exclusion Criteria:

  • Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
  • Esophageal perforation, or hematemesis.
  • History of radiotherapy or chemotherapy for esophageal cancer.
  • History of surgery within 28 days before Day 1.
  • History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
  • Participation in other interventional clinical trials within 30 days.
  • Pregnant or breast-feeding women or fertile patients who refused to use contraceptives.
  • Drug addiction, alcoholism or AIDS.
  • Uncontrolled seizures or psychiatric disorders.
  • Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
646 participants (estimated)

Study arms

  • Active comparator
    50.4Gy

    Total radiotherapy dose of 50.4Gy.

    Radiation: Radiotherapy

  • Experimental
    61.2Gy

    Total radiotherapy dose of 61.2Gy.

    Radiation: Radiotherapy

Interventions

  • RadiationRadiotherapy

    Different total radiotherapy dose between two arms.

06

What researchers measure

Primary outcomes

  1. Overall survival in PET/CT non-responders

    The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.

    Time frame: 2 years

  2. Overall survival in ITT population

    The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.

    Time frame: 2 years

Secondary outcomes

  1. Local control rate

    The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)

    Time frame: 2 years

  2. Progression-free survival

    (defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)

    Time frame: 2 years

  3. Overall survival in PET/CT responders

    Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.

    Time frame: 2 years

  4. Questionnaire EORTC-QLQ-C30

    A quality of life score is obtained according to the answers to the questionnaires.

    Time frame: 2 years

  5. Questionnaire EORTC-QLQ-OES18

    A quality of life score is obtained according to the answers to the questionnaires.

    Time frame: 2 years

07

Study locations

3 of 3 sites recruiting
  • Jiangsu Cancer Hospital
    Nanjing, Jiangsu, China
    • Jinjun C Ye, M.D. · Contact · jjye2004@163.com · 13585175433
    • Jinjun C Ye, M.D. · Principal investigator
    Recruiting
  • Huadong Hospital
    Shanghai, Shanghai 200000, China
    Recruiting
  • Fudan Universtiy Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Publications

  • Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. 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). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y. PubMed 35906623 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03790553
Lead sponsor
Fudan University
Responsible party
Kuai Le Zhao, MD (Professor, Fudan University) — Principal investigator
First posted
Dec 31, 2018
Start date
Oct 15, 2018
Primary completion
Oct 15, 2023 (estimated)
Completion
Oct 15, 2025 (estimated)
Last update
Aug 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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