MR-guidance in Chemoradiotherapy for Cervical Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06142760

Studienbeginn:
November 2023

Letztes Update:
08.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Uterine Cervical Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Juergen Debus

Collaborator:
-

Kontakt

Juliane Hörner-Rieber, MD
Kontakt:
Phone: +496221 56
Phone (ext.): 8201
E-Mail: Juliane.hoerner-rieber@med.uni-heidelbeg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Studien-Informationen

Detailed Description:

This trial will be conducted as a prospective, one-armed phase II study in 40 patients with

cervical carcinoma (FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1), age ≥ 18 years, Karnofsky

Performance Score ≥ 70%. CCRT will consist of 50.4Gy external beam radiotherapy (EBRT) with

concurrent cisplatin 40mg/m² as standard of care in Germany, followed by 27Gy of BT in 4

fractions of 7Gy.

The primary endpoint of the trial will be the occurrence of overall early bowel and bladder

toxicity CTCAE grade 2 or higher assessed within the first 3 months with NCI CTCAE Version

5.0.

Secondary outcomes to be investigated are clinical feasibility of daily CBCT-guided and

weekly MR-guided plan adaptation, local tumor control, distant tumor control,

progression-free survival, overall survival, quality of life, acquisition and comparison of

different MRI sequences, technical analyses of treatment, adaptation frequency and

morphological as well as functional tumor characteristics of the MRI.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or

adeno-squamous cell carcinoma

- FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1

- indication and eligibility for definitive chemoradiotherapy including brachytherapy

discussed in an interdisciplinary tumor board

- Karnofsky performance score ≥ 70%

- 18-80 years of age

- Capacity of the patient to consent to participation in the study

Exclusion Criteria:

- FIGO stage IIIC2 and IV

- Paraaortic lymphatic node metastases

- small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix

- previous radiotherapy of the pelvic region

- previous total or partial hysterectomy

- neoadjuvant chemotherapy

- contraindications against performing contrast-enhanced MRI scans (pacemakers, other

implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)

- claustrophobia

- pregnant or lactating women

- other primary malignancies within 5 years before except carcinoma in situ of the

cervix and basal cell carcinoma of the skin

- patient is enrolled in another study, that could influence the outcome of the

presented study

Studien-Rationale

Primary outcome:

1. Treatment-related bladder toxicity (Time Frame - within 3 month after completion of radiation treatment):
Occurrence of bladder toxicity grade 2 or higher according to CTCAE V5.0

2. Treatment-related bowl toxicity (Time Frame - within 3 month after completion of radiation treatment):
Occurrence of bowl toxicity grade 2 or higher according to CTCAE V5.0

Geprüfte Regime

MR-guided radiation:
Dayly artifical intelligence-based treatment adaptation under weekly offline MR-guidance

Quelle: ClinicalTrials.gov

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