Plan of the Day Radiotherapy

Not Applicable

Recruiting

• Conditions: Cervix Cancer
• Interventions: Radiation: Plan of the day; Radiation: Standard plan

• Registration Number: NCT05634681
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-13
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2026-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Plan of the day	-
Control arm	Standard plan	-

Primary Outcome Measures

Name	Time	Method
To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.	5 weeks	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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway