NCT07249957Toborzás még nem indult
Reducing Radiation Target Volume for Stage IIb Cervical Cancer
Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 25.
Rövid összefoglaló (regiszter, angolul)
This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size < 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2025. szept. 18.
- Kezdés
- 2025. nov.
- Elsődleges befejezés
- 2027. okt.
- Fő szponzor
- Chongqing University Cancer Hospital
- Betegségek
- Méhnyakrák
- NCT-szám
- NCT07249957
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2025. nov. és az elsődleges befejezés (2027. okt.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients who have received radiotherapy for pelvic malignant tumors in the past;
- Patients who have received partial hysterectomy or radical hysterectomy in the past;
Más betegség
- Active or uncontrolled severe infections;
- Cirrhosis, decompensated liver disease;
- History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;
- Chronic renal insufficiency and renal failure;
- Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;
- Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);
- Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;
- Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;
- Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.
Egyéb
- Patients who have undergone pelvic artery embolization;
- Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;
Kiket keres a vizsgálat
- The patient voluntarily participated in this study and signed the informed consent form;
- Age range: 50 to 75 years old;
- Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;
- According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size < 4 cm);
- ECOG score: 0 to 1, with an expected survival of more than 6 months;
- Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;
- According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.
Életkor a regiszterben: 50 év – 75 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.