NCT01224392

Brief Summary

The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

2 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

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

10.9 years

First QC Date

June 28, 2010

Last Update Submit

December 28, 2020

Conditions

Rectal Cancer

Keywords

colorectal cancercolorectal neoplasmsradiotherapychemoradiotherapyT3-4 rectal cancer

Outcome Measures

Primary Outcomes (1)

  • reduction in metabolic tumor activity

    at baseline and at 5 to 6 weeks after neo-adjuvant therapy

Secondary Outcomes (8)

  • histological downgrading (Dworak classification)

    after the rectum surgery

  • number of R0, R1 and R2 resections

    after the rectum surgery

  • acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

    at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years

  • local control

    every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

  • progression free survival

    every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

  • +3 more secondary outcomes

Study Arms (2)

Concomitant chemoradiotherapy

ACTIVE COMPARATOR

Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Other: Chemoradiotherapy

Radiotherapy with boost

EXPERIMENTAL

Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor

Radiation: Radiotherapy with boost

Interventions

ChemoradiotherapyOTHER

Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Also known as: Xeloda (capecitabine)
Concomitant chemoradiotherapy
Radiotherapy with boostRADIATION

Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor

Also known as: Preoperative radiotherapy
Radiotherapy with boost

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
  • the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

You may not qualify if:

  • unresectable metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status \> 3
  • patients not deemed fit for radiotherapy, capecitabine or surgery
  • pregnant or lactating patients
  • women with child bearing potential who lack effective contraception
  • patients below 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie

Jette, Brussels Capital, 9010, Belgium

Location

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Rectal NeoplasmsColorectal Neoplasms

Interventions

ChemoradiotherapyCapecitabineRadiotherapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Mark De Ridder, Prof.Dr.

    UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Radiotherapy Department

Study Record Dates

First Submitted

June 28, 2010

First Posted

October 20, 2010

Study Start

January 1, 2010

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations

BE(2)