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RECTAL BOOST Study

NCT01951521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2019-09-25

No results posted yet for this study

Summary

Randomized controlled trial in which the effect is investigated of a radiation boost in addition to standard chemoradiation in patients with locally advanced rectal cancer on complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.

Conditions

Interventions

RADIATION

Boost

External Beam radiation delivered using intensity modulation radiation therapy (IMRT) planning, consisting of 15 Gy (in 5 sequential fractions).

Sponsors & Collaborators

  • Maastro Clinic, The Netherlands

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • HM Verkooijen, MD PhD · Imaging Division, UMC Utrecht

  • M. Berbee, MD PhD · Radiation-Oncology, MAASTRO clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951521 on ClinicalTrials.gov