NCT06230549

Brief Summary

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

December 30, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

December 30, 2023

Last Update Submit

February 7, 2024

Conditions

Gynecological TumorAdaptive RadiotherapyRadiationCurative TreatmentOptimizationAdaptive Radiation TherapyImage Guided RadiotherapyCervical Carcinoma

Keywords

gynecological tumoradaptive radiotherapyradiationcurative treatmentoptimizationadaptive radiation therapyimage guided radiotherapyCervical carcinoma

Outcome Measures

Primary Outcomes (4)

  • Rectal Toxicity

    Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

    2 weeks to 5 years

  • Bladder Toxicity

    Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

    2 weeks to 5 years

  • Skin Toxicity

    Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

    2 weeks to 5 years

  • Lymph-Edema grade

    Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, \[score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL\]

    2 weeks to 5 years

Secondary Outcomes (2)

  • Overall Survival

    5 years

  • Progression Free Survival

    5 years

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Adaptive Radiotherapy

Radiation: Adaptive Radiotherapy

Standard conventional Treatment Arm, IGRT

ACTIVE COMPARATOR

Standard conventional Treatment Arm, IGRT

Radiation: Adaptive Radiotherapy

Interventions

Adaptive RadiotherapyRADIATION

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Also known as: Adaptive Radiation Therapy
Interventional ArmStandard conventional Treatment Arm, IGRT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG 0-1 confirmation by histophatology MR of the pelvis staging

You may not qualify if:

  • Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West

Essen, Germany / NRW, 45147, Germany

RECRUITING

Related Publications (1)

  • Guberina M, Santiago Garcia A, Khouya A, Pottgen C, Holubyev K, Ringbaek TP, Lachmuth M, Alberti Y, Hoffmann C, Hlouschek J, Gauler T, Lubcke W, Indenkampen F, Stuschke M, Guberina N. Comparison of Online-Onboard Adaptive Intensity-Modulated Radiation Therapy or Volumetric-Modulated Arc Radiotherapy With Image-Guided Radiotherapy for Patients With Gynecologic Tumors in Dependence on Fractionation and the Planning Target Volume Margin. JAMA Netw Open. 2023 Mar 1;6(3):e234066. doi: 10.1001/jamanetworkopen.2023.4066.

    PMID: 36947038BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. (MD) M. Guberina (senior consultant, specialist)

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 30, 2024

Study Start

January 15, 2024

Primary Completion

December 15, 2024

Study Completion (Estimated)

December 15, 2026

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)