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

2026. szeptember 15. frissítette: 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.

A tanulmány áttekintése

Részletes leírás

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

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

228

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

  • Név: Xiaorong Hou, Professor
  • Telefonszám: +86 18612672203
  • E-mail: houxr@pumch.cn

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

    • Beijing Municipality
      • Beijing, Beijing Municipality, Kína, 100730
        • Toborzás
        • Peking Union Medical College Hospital
        • Kapcsolatba lépni:
          • Xiaorong Hou, Professor
          • Telefonszám: +86 18612672203
          • E-mail: houxr@pumch.cn
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Egyéb: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Incidence of Acute Toxicity
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Incidence of Late Toxicity
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. szeptember 25.

Elsődleges befejezés (Becsült)

2027. december 30.

A tanulmány befejezése (Becsült)

2030. szeptember 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2025. szeptember 24.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 6.

Első közzététel (Tényleges)

2026. május 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 16.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 15.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

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