NCT05634681Recruiting
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)
Source: ClinicalTrials.gov · Last updated 2 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 22 Nov 2022
- Start date
- 13 Nov 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Oslo University Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05634681
What you commit to
- Study type: Interventional
- Planned participants: 190
- From 13 Nov 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Uncontrolled intercurrent somatic illness.
- Psychiatric illness /social situations limiting study compliance
- Patients under current treatment for other invasive s except non-melanoma skin cancers
- Patients with inflammatory bowel disease
Other
- Nephrostomy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.