Plan of the Day Radiotherapy

Oslo University Hospital190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

190

Conditions

Cervix Cancer

Interventions

Plan of the dayRADIATION

Several treatment plans are prepared and the appropriate plan is used at each treatment session.

Standard planRADIATION

One treatment plan

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 5 weeks

Central Contacts

Kjersti Bruheim, MD PhD

CONTACT

+4723934000 uxkjuh@ous-hf.no

Ingvild Deggerdal

CONTACT

+4723934000 ingdeg@ous-hf.no

Data from ClinicalTrials.gov

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