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Plan of the Day Radiotherapy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05634681
Enrollment
190
Registered
2022-12-02
Start date
2022-11-13
Completion date
2032-12-31
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Cancer

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.

Interventions

RADIATIONPlan of the day

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

RADIATIONStandard plan

One treatment plan

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.5 weeksTo 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

Countries

Norway

Contacts

Primary ContactKjersti Bruheim, MD PhD
uxkjuh@ous-hf.no+4723934000
Backup ContactIngvild Deggerdal
ingdeg@ous-hf.no+4723934000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026