NCT07295132Toborzás még nem indult2. fázis
RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)
A Randomized Clinical Trial Evaluating the Role of Secondary Cytoreductive Surgery Following Neoadjuvant Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: Patient Selection Informed by CA-125 Response Dynamics During Chemotherapy (RESCUE Study)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 19.
Rövid összefoglaló (regiszter, angolul)
This is a multicenter, prospective, randomized, open-label Phase III clinical trial (RESCUE study) evaluating the efficacy of secondary cytoreductive surgery (SCS) in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a favorable response to 3-4 cycles of platinum-based neoadjuvant chemotherapy and are assessed as highly likely to achieve complete tumor resection based on selection models. Eligible patients will be randomly assigned to either the experimental arm, receiving SCS followed by chemotherapy (with or without maintenance), or the active comparator arm, receiving chemotherapy only (with or without maintenance), with the primary objective being to compare the Progression-Free Survival (PFS) between the two groups to determine the additional clinical benefit of SCS in this carefully selected patient population.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 160 (tervezett)
- Első benyújtás
- 2025. nov. 18.
- Kezdés
- 2025. dec. 15.
- Elsődleges befejezés
- 2029. nov. 15.
- Fő szponzor
- Asan Medical Center
- Betegségek
- Petefészekrák
- NCT-szám
- NCT07295132
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 160
- 2025. dec. 15. és az elsődleges befejezés (2029. nov. 15.) 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 with a secondary malignancy treated with laparotomy and other neoplasms, where the treatment is expected to interfere with the treatment of recurrent ovarian cancer or significantly affect prognosis.
- Patients with platinum-refractory tumors (i.e., progression during chemotherapy or recurrence within 6 months after the end of the previous first platinum-containing regimen).
- Cases where only palliative surgery is planned.
- Any medical history that may cause excessive surgical risk pre- or post-operatively.
Más betegség
- Any comorbidity that precludes surgery and/or chemotherapy (e.g., poor general condition, severe infection, conditions that may cause severe bleeding, severe renal disease, etc.).
- Medications being taken that pose a significant surgical risk (e.g., oral anticoagulants, bleeding risk due to bevacizumab).
Egyéb
- Patients without recurrence
- Patients with non-epithelial tumors or borderline tumors.
- Patients with second, third, or subsequent recurrence.
- Radiological signs suggestive of metastasis that are considered completely unresectable.
- Absence of evaluable archived tumor tissue.
Kiket keres a vizsgálat
- First recurrence of platinum-sensitive, invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of initial stage.
- A progression-free interval of at least 6 months after the end of the last platinum-containing regimen.
- Demonstrated response during neoadjuvant chemotherapy after recurrence (Complete Response/Partial Response/Stable Disease according to RECIST 1.1 or GCIG CA-125 response, which is a ≥50% reduction in pre-treatment CA-125 level sustained for ≥28 days).
- Women aged 19 years or older.
- The tumor is judged to be completely resectable by surgery (R0) based on the judgment of an experienced surgeon
- Patients who provide signed and written informed consent and consent to data transfer and processing.
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