NCT01641497

Brief Summary

Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4.4 years

First QC Date

July 9, 2012

Last Update Submit

July 19, 2017

Conditions

Endometrial Cancer

Keywords

endometrial cancerIMRTage over 70

Outcome Measures

Primary Outcomes (1)

  • change from baseline in acute toxicity all along the radiation

    NCI CTCAE v 4.0 tox \> grade 2 will be compared

    baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment

Secondary Outcomes (6)

  • geriatric intervention

    up to 6 months

  • geriatric repercussion

    baseline, 6 months after end of treatment

  • duration of the radiation

    up to 5 weeks and a half

  • quality of life

    baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment

  • late major toxicity

    1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment

  • +1 more secondary outcomes

Study Arms (2)

3D conformational radiotherapy

ACTIVE COMPARATOR

25 \* 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation

Radiation: 3D conformational radiation

Intensity-Modulated Radiation Therapy

EXPERIMENTAL

25 \* 1.8 Gy in 5 weeks (=45 Gy). IMRT

Radiation: IMRT

Interventions

3D conformational radiationRADIATION

25 \* 1.8 Gy in 5 weeks (=45 Gy)

3D conformational radiotherapy
IMRTRADIATION

25 \* 1.8 Gy in 5 weeks (=45 Gy)

Intensity-Modulated Radiation Therapy

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • endometrial adenocarcinoma histologically proven
  • post op pelvic radiotherapy
  • age ≥ 70
  • performance status ≤ 2
  • MMSE ≥ 10
  • life expectancy ≥ 3 months
  • social security covered
  • signed informed consent

You may not qualify if:

  • type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
  • uterine sarcoma
  • surgery not in accordance with recommendations of Inca
  • previous uncontrolled or less than 5 years prior to diagnosis cancer
  • cons-indication for radiotherapy
  • diarrhea ≥ 3 per day
  • pelvic lymph nodes \> 1cm not resected during staging
  • previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
  • IMRT other than tomotherapy
  • photon energy \< 10MV
  • patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bergonie Institut

Bordeaux, 33076, France

Location

François Baclesse Center

Caen, 14076, France

Location

Oscar Lambret Center

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Jean Godinot

Reims, 51726, France

Location

René Gauducheau Center

Saint-Herblain, 44805, France

Location

Paul Strauss Center

Strasbourg, 67065, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Le Tinier Florence, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 16, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)