Clinical trial · Interventional
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)
NCT05634681CI-TRIAL-00062452recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plan of the day | Radiation | — | UNRESOLVED |
| Standard plan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- interventionNames
- Radiation: Plan of the day
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- interventionNames
- Radiation: Standard plan
Primary outcomes (1)
- measure
- To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.
- timeFrame
- 5 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.