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

2026년 5월 6일 업데이트: Xiaorong Hou

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

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.

연구 개요

상세 설명

Randomization:

Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.

Control Group: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.

Stratification Factors for Randomization:Participating study center; Disease type (Cervical cancer / Endometrial cancer); Receipt of concurrent chemotherapy

Study Objectives:

Primary Endpoint: Acute adverse reactions/toxicity Secondary Endpoints: Late adverse reactions/toxicity, 3-year local control rate, 3-year distant metastasis rate, 3-year progression-free survival (PFS), 3-year overall survival (OS), 3-year disease-free survival (DFS), quality of life, cost-effectiveness analysis related to treatment.

Study Population:

Planned Sample Size: 228 participants

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 ≥18 years and ≤75 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 ± 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).
  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 ≥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.

Study Duration: September 2025 to September 2030 Participant Involvement Period: Follow-up for over 3 years after radiotherapy

연구 유형

중재적

등록 (추정된)

228

단계

  • 해당 없음

연락처 및 위치

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연구 연락처

  • 이름: Xiaorong Hou, Professor
  • 전화번호: +86 18612672203
  • 이메일: houxr@pumch.cn

연구 연락처 백업

연구 장소

    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100730
        • Peking Union Medical College Hospital
        • 연락하다:
          • Xiaorong Hou, Professor
          • 전화번호: +86 18612672203
          • 이메일: houxr@pumch.cn
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

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아니

설명

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 ≥18 years and ≤75 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 ± 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).
  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 ≥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.

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: MH-ART
Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
Treatment will be delivered using an online adaptive radiotherapy device. A moderately fractionated regimen will be employed, with a prescribed dose of 40.05 Gy in 15 fractions, administered once daily, five times per week.
다른: CF-IMRT
Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Intensity-modulated radiotherapy techniques will be used, including FF-IMRT, VMAT, or TOMO. A conventionally fractionated regimen will be employed, with a prescribed dose of 45 Gy in 25 fractions, administered once daily, five times per week.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Acute Toxicity
기간: Within 90 days (inclusive) from the start of radiotherapy
Toxicities occurring within 90 days (inclusive) from the start of radiotherapy are defined as acute toxicities. Acute toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Within 90 days (inclusive) from the start of radiotherapy

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence of Late Toxicity
기간: From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.
Toxicities occurring more than 90 days after the start of radiotherapy are defined as late toxicities. Late toxicities will be evaluated using the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.
3 years Local Recurrence Rate
기간: From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.
The proportion of subjects who do not experience tumor recurrence or progression within the radiation field within 3 years after the end of radiotherapy.
From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.
3 years Distant Metastasis Rate
기간: From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.
The proportion of subjects who develop distant metastasis within 3 years after the start of radiotherapy.
From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.
3 years Progression-Free Survival
기간: From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.
The time interval from the start of radiotherapy to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause within 3 years after the start of radiotherapy.
From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.
3 years Overall Survival
기간: From the start of radiotherapy until death from any cause, assessed up to 3 years.
The time interval from the start of radiotherapy to death from any cause within 3 years after the start of radiotherapy.
From the start of radiotherapy until death from any cause, assessed up to 3 years.
3 years Disease-Free Survival
기간: From the start of radiotherapy until the first local/regional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.
The time interval from the start of radiotherapy to the first occurrence of local or regional recurrence, distant metastasis, or death from any cause within 3 years after the start of radiotherapy.
From the start of radiotherapy until the first local/regional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.
Quality of Life
기간: Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.
Quality of life will be assessed using the QLQ-C30 questionnaire, in combination with the disease-specific module (QLQ-CX24 for cervical cancer; QLQ-EN24 for endometrial cancer).
Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.
Treatment-Related Cost-Effectiveness Analysis
기간: From the start of radiotherapy until death from any cause, assessed up to 3 years.
The cost assessment should cover both medical costs and non-medical costs.
From the start of radiotherapy until death from any cause, assessed up to 3 years.

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2030년 9월 30일

연구 등록 날짜

최초 제출

2025년 9월 24일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 13일

QC 기준을 충족하는 마지막 업데이트 제출

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