NCT00576563

Brief Summary

To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

7.8 years

First QC Date

December 18, 2007

Last Update Submit

April 20, 2016

Conditions

Rectum Cancer

Keywords

rectal cancerblood proteinsirradiationFDG-PET-CT

Outcome Measures

Primary Outcomes (1)

  • The metabolic tumour response by PET scan will be determined according to the EORTC criteria (appendix 1)61. The pathological tumour response will be determined according to Dworak and Wheeler.62,63

    5 years

Secondary Outcomes (1)

  • Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions)

    5 years

Study Arms (1)

FDG PET CT

OTHER

To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy.

Drug: FDG

Interventions

FDGDRUG

contrast medium

Also known as: Omnipaque 350/ 18 Fluor FDG
FDG PET CT

Eligibility Criteria

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

You may qualify if:

  • Histological proven rectal cancer
  • UICC stage I-IV
  • WHO performance status 0-2
  • Less than 10 % weight loss in the last 6 months
  • In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course
  • No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure,infarction)
  • Life expectancy more than 6 months
  • Measurable cancer
  • Willing and able to comply with the study prescriptions
  • years or older
  • Not pregnant and willing to take adequate contraceptive measures during the study
  • Have given written informed consent before patient registration
  • No previous radiotherapy to the pelvis

You may not qualify if:

  • Not adenocarcinoma histology
  • History of prior pelvis radiotherapy
  • Recent (\< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Less than 18 years old
  • Pregnant or not willing to take adequate contraceptive measures during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Iohexol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Guido Lammering, MD PHD

    Maastricht Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

NL(1)