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Recruiting

NCT Number: NCT05634681

Plan of the Day Radiotherapy

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.

Recruiting

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Key information

Conditions

Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0379, Norway

Location status: Recruiting

Location contact

Kjersti Bruheim, MD PhD

CONTACT

[email protected]

+4723934000

Silje Skjelsvik Os, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plan of the day

Radiation

Several treatment plans are prepared and the appropriate plan is used at each treatment session.

Standard plan

Radiation

One treatment plan

Primary outcomes

  1. To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.

    Time frame: 5 weeks

    To compare the change in patient reported acute diarrhea from baseline to week 4 from start of the treatment and to the end of external radiotherapy.

    Item 17 in EORTC QLQ-C30

Study contacts

Contact information is provided by the study sponsor or research team.

Ingvild Deggerdal

CONTACT

[email protected]

+4723934000

Kjersti Bruheim, MD PhD

CONTACT

[email protected]

+4723934000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)

Important dates

Study start
2022
Primary completion
2026
Study completion
2032
First posted
Dec 2, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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