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Recruiting NCT05634681

NCT05634681 Plan of the Day Radiotherapy

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Clinical Trial Summary
NCT ID NCT05634681
Status Recruiting
Phase
Sponsor Oslo University Hospital
Condition Cervix Cancer
Study Type INTERVENTIONAL
Enrollment 190 participants
Start Date 2022-11-13
Primary Completion 2026-12-31

Trial Parameters

Condition Cervix Cancer
Sponsor Oslo University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 190
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-11-13
Completion 2026-12-31
Interventions
Plan of the dayStandard plan

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Brief Summary

The study objectives are to improve the treatment of LACC patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed cervical cancer eligible for definitve radiochemotherapy * FIGO stage IB1-IVa * Over 18 years * Speaks and understands Norwegian or English. * ECOG 0-2 * Histology: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma * Ability to understand and fill in patient questionnaires, and willing to sign a written informed consent * Large movers (LM), fundus movement ≥2,5 cm. Exclusion Criteria: * Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field * Patients with previous surgery for their cervical cancer * Uncontrolled intercurrent somatic illness. * Psychiatric illness /social situations limiting study compliance * Prior radiotherapy to the pelvis * Patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infant

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