Chemoradiation therapy for esophageal cancer recurrence after surgery
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
This study is testing a new treatment combining chemotherapy and radiation for people with esophageal cancer that has come back after surgery to see if it helps them live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | ChineseAMS |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03731442 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of chemoradiation therapy in patients with esophageal cancer who experience locoregional recurrence after radical or palliative surgery. It aims to address the high recurrence rates and lack of effective adjuvant therapies for these patients. The trial will utilize simultaneously integrated boost intensity-modulated radiation therapy (IMRT) combined with chemotherapy agents such as Paclitaxel and Platinum. The study will assess overall survival rates and optimal radiation doses based on previous retrospective data indicating improved outcomes with salvage chemoradiation.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16-70 with locoregional recurrence after radical surgery and positive resection margins.
Not a fit: Patients over 70 years old, those with severe comorbidities, or those who have had prior therapy after recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with recurrent esophageal cancer after surgery.
How similar studies have performed: Previous studies have shown improved survival rates with similar salvage chemoradiation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Locoregional recurrence after radical surgery; * Positive resection margin (R1/R2) after surgery; * Out-of-field recurrence after adjuvant chemoradiation or radiotherapy; * Recurrence after adjuvant chemotherapy; * No prior therapy after recurrence; * Age 16-70 years; * KPS\>70; * No history of drug allergy; * Sufficient liver and kidney functions; * White blood cell count \> 4.0\*10\^9/L. Exclusion Criteria: * Age\>70 or \<16 years; * Pregnancy or lactation; * History of drug allergy; * Declining informed consent; * Insufficient liver or kidney functions, or abnormal CBC test; * Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
Where this trial is running
Beijing, Beijing Municipality
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zefen Xiao, MD
- Email: xiaozefen@sina.com
- Phone: +86-13621018159
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.