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Plan of the Day Radiotherapy

Primary Purpose

Cervix Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Plan of the day
Standard plan
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
November 22, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05634681
Brief Title
Plan of the Day Radiotherapy
Official Title
Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Title
Control arm
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Plan of the day
Intervention Description
Several treatment plans are prepared and the appropriate plan is used at each treatment session.
Intervention Type
Radiation
Intervention Name(s)
Standard plan
Intervention Description
One treatment plan
Primary Outcome Measure Information:
Title
To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.
Description
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
Time Frame
5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kjersti Bruheim, MD PhD
Phone
+4723934000
Email
uxkjuh@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingvild Deggerdal
Phone
+4723934000
Email
ingdeg@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjersti Bruheim, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kjersti Bruheim, MD PhD
Phone
+4723934000
Email
uxkjuh@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Silje Skjelsvik Os, MD

12. IPD Sharing Statement

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Plan of the Day Radiotherapy

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