Plan of the Day Radiotherapy | NCT05634681

Studies
Plan of the Day Radiotherapy

NCT05634681

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

Dec 2, 2022Actual

Enrollment

190Estimated

Phase

Not Applicable

Conditions

Cervix Cancer

Interventions

Plan of the day
Standard plan

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Nov 22, 2022

First Submission Date that Met QC Criteria

Nov 22, 2022

First Posted Date

Dec 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2022

Last Update Posted Date

Dec 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental		Radiation: Plan of the day
Control arm	Active Comparator		Radiation: Standard plan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plan of the day	Radiation	Several treatment plans are prepared and the appropriate plan is used at each treatment session.	Intervention arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kjersti Bruheim, MD PhD	Contact	+4723934000		uxkjuh@ous-hf.no
Ingvild Deggerdal	Contact	+4723934000		ingdeg@ous-hf.no

Overall Officials

Name	Affiliation	Role
Kjersti Bruheim, MD PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo		0379	Norway

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided