NCT07584161Toboroz
MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer
A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy(MH-ART) vs. Conventional Fractionated Intensity-Modulated Radiotherapy(CF-IMRT) in Postoperative Cervical Cancer and Endometrial Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 16.
Rövid összefoglaló (regiszter, angolul)
This is an investigator-initiated, prospective, national multi-center, phase III, randomized, open-label, non-inferiority clinical study. The hypothesis is that using online adaptive radiotherapy technology for moderately fractionated radiotherapy in post-operative patients with cervical/endometrial cancer may reduce radiotherapy-related toxicity and improve quality of life while ensuring target coverage. The objective is to evaluate treatment-related toxicity and efficacy of moderately fractionated online adaptive radiotherapy compared to conventionally fractionated intensity-modulated radiotherapy in post-operative cervical and endometrial cancer patients, aiming to provide a more precise, convenient, and cost-effective treatment option for patients.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 228 (tervezett)
- Első benyújtás
- 2025. szept. 24.
- Kezdés
- 2025. szept. 25.
- Elsődleges befejezés
- 2027. dec. 30.
- Fő szponzor
- Xiaorong Hou
- Betegségek
- Méhtestrák, Méhnyakrák
- NCT-szám
- NCT07584161
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 228
- 2025. szept. 25. és az elsődleges befejezés (2027. dec. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Requirement for extended-field radiotherapy encompassing the para-aortic region;
- Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered;
- History of previous abdominal or pelvic radiotherapy;
- History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast);
Más betegség
- History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;
- Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types;
- Presence of active infection or fever;
- Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.
Egyéb
- Presence of confirmed distant metastasis or para-aortic lymph node metastasis;
- Pregnant or lactating women;
Kiket keres a vizsgálat
- Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
- Age ≥18 years and ≤75 years.
- ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
- Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy).
- For participants with cervical cancer, the following criteria must be met:
- (1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.
- (2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.
- Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.
- 6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1.
- Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).
- 7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
- 8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
- 9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.
Életkor a regiszterben: 18 év – 75 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Peking Union Medical College Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Beijing | Kína | Toboroz |
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