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Plan of the Day Radiotherapy

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Enrolling

Conditions

Cervix Cancer

Treatments

Radiation: Standard plan
Radiation: Plan of the day

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

190 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

190 participants in 2 patient groups

Intervention arm
Experimental group
Treatment:
Radiation: Plan of the day
Control arm
Active Comparator group
Treatment:
Radiation: Standard plan

Trial contacts and locations

1

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Central trial contact

Kjersti Bruheim, MD PhD; Ingvild Deggerdal

Data sourced from clinicaltrials.gov

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