A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial… (NCT06160557) | Clinical Trial Compass
By InvitationNot Applicable
A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma
China40 participantsStarted 2023-11-29
Plain-language summary
The goal of observational study is to learn about the outcomes of the participants. The main questions it aims to answer are:
1. ESD additional postoperative radiotherapy in patients with non healing SESCC overall survival (OS) and disease-free survival (DFS)
2. The adverse events (AE) of additional radiotherapy after ESD for non-curative SESCC patients were counted, and its safety was evaluated.
Participants will receive radiation therapy as necessary.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* (1) patients with esophageal squamous cell carcinoma within pT1 (stage pT1N0M0) confirmed by pathology;
* (2) The following conditions were confirmed by pathology after ESD: submucosal invasion \> 200μm (stage SM2-SM3), undifferentiated or poorly differentiated pathological degree, positive surgical margin, vascular and lymphatic invasion;
* (3) aged 18-75 years old (inclusive);
* (4) predicted survival time ≥6 months;
* (5) ECOG score of 0-1;
* (6) no obvious other symptoms or no effect assessed by researchers;
* (7) Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male or female patients of childbearing potential volunteered to use an effective contraceptive method, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study and for 90 days after the last study medication was taken. All female patients will be considered fertile unless the woman has undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy);
* (8) Electrocardiogram, blood, biochemical and other basic examinations had no contraindications to radiotherapy, and had sufficient bone marrow, liver and kidney organ functions. Laboratory examinations within 7 days before the first dose of medication met the following requirements: a. Absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L and hemoglobin ≥90g/L (no…
What they're measuring
1
Overall Survival, OS
Timeframe: It continued for 3 years after enrollment
2
Disease Free Survival, DFS
Timeframe: It continued for 3 years after enrollment