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MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer

RecruitingNAAges 18 Years - 75 YearsFemaleXiaorong Hou
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment. 2. Age โ‰ฅ18 years and โ‰ค75 years. 3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour. 4. Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ยฑ para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ยฑ pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy). 5. 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 โ‰ฅ4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size โ‰ฅ2cm, 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 โ‰ฅ70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age โ‰ฅ60 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 โ‰ฅ4 cycles. 9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned. Exclusion Criteria: 1. Presence of confirmed distant metastasis or para-aortic lymph node metastasis; 2. Requirement for extended-field radiotherapy encompassing the para-aortic region; 3. 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; 4. History of previous abdominal or pelvic radiotherapy; 5. History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast); 6. History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease; 7. 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; 8. Pregnant or lactating women; 9. Presence of active infection or fever; 10. 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.
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What it tests

  • Moderately fractionated radiotherapy using online adaptive radiotherapy technology
  • Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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