רדאר קליני AI | ||
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הניסוי הקליני NCT07402525 (PORT-ESTER) עבור Oral Tongue Squamous Cell Carcinoma הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial (PORT-ESTER) 190 אקראי תווית פתוחה הישרדות כוללת
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07402525 (PORT-ESTER) הוא מחקר מסוג התערבותי עבור Oral Tongue Squamous Cell Carcinoma, שנמצא כעת במצב מגייס. המחקר התחיל ב-26 בינואר 2026 ומתוכנן לכלול 190 משתתפים. המחקר מנוהל על ידי Second Affiliated Hospital, School of Medicine, Zhejiang University וצפוי להסתיים ב-30 ביולי 2031. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-11 בפברואר 2026.
סיכום קצר
The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that o...הצג עוד
כותרת רשמית
Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial
מצבים רפואיים
Oral Tongue Squamous Cell Carcinomaמזהי מחקר נוספים
- PORT-ESTER
- 2025-0846
מספר NCT
תחילת המחקר (בפועל)
2026-01-26
עדכון אחרון שפורסם
2026-02-11
סיום המחקר (מוערך)
2031-07-30
משתתפים (מתוכנן)
190
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיPORT group Patients should start radiotherapy immediately after the surgical wound has fully healed, usually 4 to 6 weeks after surgery, with a requirement of no later than 8 weeks after surgery | קרינה לאחר ניתוח Radiation therapy should commence immediately after the surgical wound has fully healed, typically 4 to 6 weeks post-operation, but no later than 8 weeks post-operation |
ללא טיפולcontrol group Patients will not receive special treatment and will undergo routine follow-up. | לא ישים |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
3-year DFS | The survival time of patients without significant tumor growth from the date of randomization. The appearance of new lesions is used as the criterion for recurrence (including recurrence of the primary lesion and surrounding tissues, cervical lymph node metastasis, and distant metastasis), and the time point of recurrence is the date of the first observation of measurable new lesions. The disease-free survival period will be defined as the time from randomization to death for patients who die from any other cause before disease recurrence is recorded. Patients who have not experienced disease recurrence or death (i.e. disease-free survival) during analysis will have the time of the last efficacy evaluation as the endpoint. For disease-free survival patients who have not undergone tumor evaluation since the baseline period, the first day of treatment will be used as the endpoint of disease-free survival. Calculate the 3-year disease-free survival rate of all patients after follow-up. | 3 years |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
5-year OS | From the date of randomization to the time of death caused by any reason. When recording lost patients until death, up to the last recorded time of contact with the patient. For patients who are still alive at the final analysis time point, their last contact time will be used as the survival time. During the analysis of survival and subsequent treatment, all patients were followed up until death, loss to follow-up, or termination of the study. The log rank test will be used to analyze the 5-year overall survival of all participants. | 5 years |
5-year DFS | The definition is the same as above. Calculate the 5-year disease-free survival rate of all patients after follow-up. | 5 years |
acute toxicity events | Evaluate toxicity events within 6 months after radiotherapy according to the RTOG acute radiation injury grading criteria and CTCAE v5.0 criteria. | 6 months |
Long-term toxicity events | according to CTCAE 5.0 | from 6 months after treatment to 5 years after treatment |
scores of Quality of life | according to The University of Washington Quality of Life 4.0 | From enrollment to 5 years |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- Age ≥ 18 years old and ≤ 70 years old, gender not limited;
- Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
- Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
- The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
- Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
- According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
- Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
- The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
- Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled.
- Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
- Have received chemotherapy or other anti-tumor drugs;
- Previously received radiation therapy for the head and neck area;
- Patients with active autoimmune diseases that require systemic treatment in the past;
- Pregnant or lactating women;
- Individuals with acute infections that are difficult to control;
- Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
- The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);
- Researchers believe that there are other conditions that hinder patients from participating in this trial.
Second Affiliated Hospital, School of Medicine, Zhejiang Universityהגורם האחראי למחקר
Qichun Wei, MD, PhD, חוקר ראשי, professor of medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
אין נתוני קשר.
28 מיקומי המחקר ב-1 מדינות
Anhui
The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233030, China
Hao Jiang, איש קשר, 0552-3086120, [email protected]
טרם החל גיוס
Beijing Municipality
Cancer Hospital Chinese Academy of Medical Sciences, Chaoyang, Beijing Municipality, 100020, China
Ye Zhang, איש קשר, +86-13717635880, [email protected]
טרם החל גיוס
Fujian
Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China
Sufang Qiu, איש קשר, 0591-83660063, [email protected]
טרם החל גיוס
Guangdong
Cancer prevention and treatment center, sun yat-sen university, Guandong, Guangdong, 510060, China
Fei Han, איש קשר, 020-87343535, [email protected]
טרם החל גיוס
Heilongjiang
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150081, China
Chuncheng Hao, איש קשר, 0451-86298666, [email protected]
טרם החל גיוס
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China
Guangyuan Hu, איש קשר, 027-83662688, [email protected]
טרם החל גיוס
Renmin Hospital of Wuhan University, Wuhan, Hubei, 430060, China
Xiangpan Li, איש קשר, 027-88041911, [email protected]
טרם החל גיוס
Hunan
Hunan Provincial People's Hospital, Changsha, Hunan, 410005, China
Huaxin Duan, איש קשר, 0731-83929900, [email protected]
טרם החל גיוס
Hunan cancer hospital, Changsha, Hunan, 410008, China
Yaqian Han, MD/PhD, איש קשר, +86-18673176667, [email protected]
טרם החל גיוס
Jiangxi
Jiangxi Cancer Hospital, Nanchang, Jiangxi, 330029, China
Xiaochang Gong, איש קשר, 0791-833322, [email protected]
טרם החל גיוס
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130033, China
Xin Jiang, איש קשר, 0431-88782222, [email protected]
טרם החל גיוס
Liaoning
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China
Xiupeng Lv, איש קשר, 0411-83635963, [email protected]
טרם החל גיוס
The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116027, China
Haichen Zhang, איש קשר, 0411-84671291, [email protected]
טרם החל גיוס
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, 110001, China
Qiao Qiao, איש קשר, 024-961200, [email protected]
טרם החל גיוס
Shaanxi
the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China
Rui Liu, איש קשר, 029-85323112, [email protected]
טרם החל גיוס
Shandong
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China
Haijun Lu, איש קשר, 0532-82911847, [email protected]
טרם החל גיוס
Shanghai Municipality
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, 200032, China
Chaosu Hu, איש קשר, 021-64175590, [email protected]
טרם החל גיוס
The Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai Municipality, 200040, China
Yang Wang, איש קשר, 021-54601999, [email protected]
טרם החל גיוס
Sichuan
Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, 610041, China
Shun Lu, איש קשר, 028-85420243, [email protected]
טרם החל גיוס
Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin Municipality, 300060, China
Peiguo Wang, איש קשר, 022-23340123, [email protected]
טרם החל גיוס
Zhejiang
The first affiliated hospital, college of medicinle, Zhejiang University, Hangzhou, Zhejiang, 310009, China
Senxiang Yan, איש קשר, +86-13957162839, [email protected]
מגייס
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310009, China
Feng Jiang, MD/PhD, איש קשר, +86-13858065192, [email protected]
טרם החל גיוס
the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009, Hangzhou, Zhejiang, China
Qichun Wei, MD/PhD, איש קשר, +86 571 87783521, [email protected]
Qiaoying Tian, MD/PhD, איש קשר, +86-19858131366, [email protected]
מגייס
Huzhou Center Hospital, Huzhou, Zhejiang, 313000, China
Lixin Ru, איש קשר, 0572-2023301, [email protected]
טרם החל גיוס
Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, 315040, China
Zhenfei Xiang, איש קשר, 0574-55835583, [email protected]
טרם החל גיוס
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Changlin Zou, איש קשר, 0577-55578037, [email protected]
טרם החל גיוס
Xiangya Hospital of Central South University, Changsha, 410008, China
Haijun Wu, איש קשר, 0731-4328888, [email protected]
טרם החל גיוס
The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, China
Jinsheng Hong, איש קשר, 0591-88712222, [email protected]
טרם החל גיוס