NCT02880007

Brief Summary

This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

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 Start

First participant enrolled

June 6, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

August 10, 2016

Last Update Submit

March 6, 2020

Conditions

Cervical AdenocarcinomaStage IB Cervical CancerStage II Cervical CancerStage III Cervical Cancer

Keywords

Pulsed dose-rate brachytherapy3D dosimetryProspective StudiesRadiotherapy DosageUterine Cervical Neoplasms/radiotherapyBrachytherapy/methods

Outcome Measures

Primary Outcomes (1)

  • Increase the local control rate

    Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms

    24 months

Secondary Outcomes (3)

  • Maintain the cumulative rate grade III and IV complications below 6.5%

    24 months

  • Relationship between the doses delivered to the target volume and local control

    24 months

  • Relationship between the doses delivered to the critical organs and rate of grade III and IV complications

    24 months

Study Arms (1)

ARM A

EXPERIMENTAL

Dose Optimization in 3D Pulsed Dose Rate Brachytherapy

Radiation: External Beam Radiation TherapyRadiation: PDR BrachytherapyDrug: Cisplatin

Interventions

External Beam Radiation TherapyRADIATION

45 Gy pelvis / 25 fr

Also known as: EBRT
ARM A
PDR BrachytherapyRADIATION

1 puls/hour ; 12 Gy / day

ARM A
CisplatinDRUG

increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy

Also known as: CDDP
ARM A

Eligibility Criteria

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

You may qualify if:

  • primitive cervical cancer
  • adenocarcinoma histologically advanced
  • IB2, II and III stage
  • curative treatment
  • indication of utero-vaginal brachytherapy with external radiotherapy
  • non-metastatic tumor and life expectancy \> 6 months
  • patient informed and follow possible
  • performance status ≤ 2
  • unplanned surgery
  • age ≥ 18 years old
  • ability to provide written informed consent before the start of any study specific procedures

You may not qualify if:

  • primitive endometrial cancer
  • other diseases
  • carcinoma in situ and stages ≤ B
  • distant metastases
  • history of pelvic irradiation or a first pelvic cancer
  • contraindication to MRI
  • history of subtotal or total hysterectomy
  • pregnant or breast feeding females
  • inability to support low dose rate continuous brachytherapy or pulsed flow
  • person in emergencies
  • person unable to give personally consent
  • patient participating in another clinical research except in case of local recurrence or observational research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU de Besançon

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Georges-François Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Claudius Regaud

Toulouse, 31052, France

Location

CHRU Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • PEIFFERT Didier

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 26, 2016

Study Start

June 6, 2011

Primary Completion

February 10, 2014

Study Completion

July 1, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)