Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

Rectal Cancer Clinical Trial

— RectumSIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224392
• Other study ID #: RectumSIB
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Belgium	UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie	Jette	Brussel
Belgium	UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in metabolic tumor activity		at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Secondary	histological downgrading (Dworak classification)	pathological evaluation of surgical resection specimens	after the rectum surgery
Secondary	number of R0, R1 and R2 resections	pathological evaluation of surgical resection specimens	after the rectum surgery
Secondary	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
Secondary	local control		every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Secondary	progression free survival		every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Secondary	survival	overall survival	every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Secondary	quality of life		at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Secondary	cost evaluation		during the treatment and follow-ups