Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

15 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

228

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Contact Back-up

Studie Locaties

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Werving
        • Peking Union Medical College Hospital
        • Contact:
          • Xiaorong Hou, Professor
          • Telefoonnummer: +86 18612672203
          • E-mail: houxr@pumch.cn
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Acute Toxicity
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Late Toxicity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 september 2025

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 september 2030

Studieregistratiedata

Eerst ingediend

24 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren