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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cervix Cancer
• Intervention / Treatment: Radiation: Plan of the day; Radiation: Standard plan

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kjersti Bruheim, MD PhD; Phone Number: +4723934000; Email: uxkjuh@ous-hf.no
• Study Contact Backup: Name: Ingvild Deggerdal; Phone Number: +4723934000; Email: ingdeg@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0379
    • Recruiting
    • Oslo University Hospital
    • Contact: Kjersti Bruheim, MD PhD; Phone Number: +4723934000; Email: uxkjuh@ous-hf.no
    • Sub-Investigator: Silje Skjelsvik Os, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm	Radiation: Plan of the day; Several treatment plans are prepared and the appropriate plan is used at each treatment session.
Active Comparator: Control arm	Radiation: Standard plan; One treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Kjersti Bruheim, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2022
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 236807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No