Improving radiotherapy for cervical cancer patients
Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)
NA · Oslo University Hospital · NCT05634681
This study is testing a new daily approach to radiotherapy for patients with advanced cervical cancer to see if it can improve treatment results and reduce side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Oslo University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05634681 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the treatment outcomes for patients with locally advanced cervical cancer (LACC) by implementing a 'plan-of-the-day' approach to radiotherapy. The focus is on assessing the potential benefits of this method in reducing side effects during and after treatment. Eligible participants will receive either the standard treatment plan or the new plan-of-the-day intervention, with their experiences and side effects monitored throughout the process.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed cervical cancer at FIGO stage IB1-IVa who can understand and complete patient questionnaires.
Not a fit: Patients with distant metastasis, prior pelvic radiotherapy, or significant uncontrolled illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced side effects and improved quality of life for cervical cancer patients undergoing radiotherapy.
How similar studies have performed: While the specific 'plan-of-the-day' approach may be novel, similar studies have shown promise in optimizing radiotherapy protocols for various cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Kjersti Bruheim, MD PhD — Oslo University Hospital
- Study coordinator: Kjersti Bruheim, MD PhD
- Email: uxkjuh@ous-hf.no
- Phone: +4723934000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervix Cancer