Comparing two doses of radiotherapy for advanced esophageal cancer
A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
This study is testing whether a higher dose of radiotherapy can help people with advanced esophageal cancer feel better compared to a standard dose.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 646 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Trial ID | NCT03790553 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma by comparing a higher dose of 61.2 Gy to a standard dose of 50.4 Gy. Participants will receive radiotherapy and will be monitored for treatment efficacy and safety. The study will include patients aged 18-75 with confirmed esophageal cancer who have not undergone prior treatments. The effectiveness of the treatment will be assessed using PET/CT imaging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with locally advanced esophageal squamous cell carcinoma who have not received prior treatments.
Not a fit: Patients with severe organ dysfunction or those who have previously undergone radiotherapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with locally advanced esophageal cancer.
How similar studies have performed: Other studies have shown varying success with different radiotherapy doses for esophageal cancer, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu and 2 other locations
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
- Huadong Hospital — Shanghai, Shanghai, China (Recruiting)
- Fudan Universtiy Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.