NCT01619696

Brief Summary

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

June 12, 2012

Last Update Submit

January 22, 2013

Conditions

Rectal Adenocarcinoma

Keywords

chemotherapyrectal adenocarcinomaproctectomyFmiso TEPMRI

Outcome Measures

Primary Outcomes (1)

  • acceptation rate of the entire sequence by eligible patients

    acceptation rate of the entire sequence by eligible patients

    13 weeks

Secondary Outcomes (1)

  • radiological changes while on chimiotherapy, to tumour regression, and prognosis

    13 weeks

Study Arms (1)

Intervention

EXPERIMENTAL
Procedure: Pelvic MRI and F MISO TEP

Interventions

Pelvic MRI and F MISO TEPPROCEDURE

Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.

You may not qualify if:

  • synchonous metastatis
  • previous malignant tumour
  • previous radiotherapy/ chemotherapy
  • performance status WHO\>2
  • contraindication to 5 FU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, Toulouse, 31059, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Guillaume Portier, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

FR(1)