Status:
RECRUITING
MR-guidance in Chemoradiotherapy for Cervical Cancer
Lead Sponsor:
Juergen Debus
Conditions:
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy (EBRT) and chemotherapy, followed by brachytherapy (BT) is the standard of care for patients with locally advanced cervica...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06142760
Start Date
November 15 2023
End Date
May 1 2026
Last Update
January 8 2024
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120