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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2025-10-15

Brief Summary

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

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50.4Gy

Total radiotherapy dose of 50.4Gy.

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

Different total radiotherapy dose between two arms.

61.2Gy

Total radiotherapy dose of 61.2Gy.

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Different total radiotherapy dose between two arms.

Interventions

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Radiotherapy

Different total radiotherapy dose between two arms.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No