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NCT Number: NCT01224392

Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

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

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Key information

Conditions

Rectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie, Jette, Brussels Capital, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemoradiotherapy

Other

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

Other names: Xeloda (capecitabine)

Radiotherapy with boost

Radiation

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

Other names: Preoperative radiotherapy

Primary outcomes

  1. reduction in metabolic tumor activity

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

Secondary outcomes

  1. histological downgrading (Dworak classification)

    Time frame: after the rectum surgery

    pathological evaluation of surgical resection specimens

  2. number of R0, R1 and R2 resections

    Time frame: after the rectum surgery

    pathological evaluation of surgical resection specimens

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

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

  4. local control

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

  5. progression free survival

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

  6. survival

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

    overall survival

  7. quality of life

    Time frame: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

  8. cost evaluation

    Time frame: during the treatment and follow-ups

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Vrije Universiteit Brussel

Registry information

Official study title

Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer

Acronym: RectumSIB

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2010
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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