NCT03731442 Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
| NCT ID | NCT03731442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chinese Academy of Medical Sciences |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-11-01 |
| Primary Completion | 2022-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2018-11-01 with a primary completion date of 2022-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03731442 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03731442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT03731442 currently recruiting?
Yes, NCT03731442 is actively recruiting participants. Contact the research team at xiaozefen@sina.com for enrollment information.
Where is the NCT03731442 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT03731442 clinical trial?
NCT03731442 is sponsored by Chinese Academy of Medical Sciences. The trial plans to enroll 300 participants.
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