Plan of the Day Radiotherapy

Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634681
• Other study ID #: 236807
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: November 2022
• Source: Oslo University Hospital
• Contact: Kjersti Bruheim, MD PhD
• Phone: +4723934000
• Email: uxkjuh[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Plan of the day
Several treatment plans are prepared and the appropriate plan is used at each treatment session.
• Standard plan
One treatment plan

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.	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	5 weeks