Clinical trial NCT03790553: Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Official title: A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: chemoradiotherapy
esophageal cancer
PET/CT
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Overall survival in PET/CT non-responders
timeFrame: 2 years
measure: Overall survival in ITT population
timeFrame: 2 years
Secondary outcomes:
measure: Local control rate
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival in PET/CT responders
timeFrame: 2 years
measure: Questionnaire EORTC-QLQ-C30
timeFrame: 2 years
measure: Questionnaire EORTC-QLQ-OES18
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Huadong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Center
state: Shanghai
Study officials:
References:
citation: 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.