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Trial Title:
Plan of the Day Radiotherapy
NCT ID:
NCT05634681
Condition:
Cervix Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Radiation
Intervention name:
Plan of the day
Description:
Several treatment plans are prepared and the appropriate plan is used at each treatment
session.
Arm group label:
Intervention arm
Intervention type:
Radiation
Intervention name:
Standard plan
Description:
One treatment plan
Arm group label:
Control arm
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.
Criteria for 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 infants
- Patients under current treatment for other invasive s except non-melanoma skin
cancers
- Nephrostomy
- Patients with inflammatory bowel disease
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Kjersti Bruheim, MD PhD
Phone:
+4723934000
Email:
uxkjuh@ous-hf.no
Investigator:
Last name:
Silje Skjelsvik Os, MD
Email:
Sub-Investigator
Start date:
November 13, 2022
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634681
