Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer (RectumSIB)

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 3

Conditions: Rectal Cancer

Treatments: Other: Chemoradiotherapy; Radiation: Radiotherapy with boost

Study type: Interventional

Funder types: Other

Identifiers

NCT01224392

RectumSIB

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Concomitant chemoradiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Chemoradiotherapy

Radiotherapy with boost

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy with boost