RECTAL BOOST Study

NCT01951521 | Unknown DMC

• 1 other identifier: NL46051.041.13
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Rectal Cancer

Keywords

Rectal cancer; Locally advanced rectal cancer; Radiotherapy; Boost; Dose-escalation; Pathological complete response; Response

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach.

  pathologic examination following surgery, at aproximately 13-15 weeks (control arm) or 14-16 weeks (boost arm) after randomization or clinical complete respons of 2 years after first response assessment.

Secondary Outcomes (6)

• Acute toxicity in common toxicity criteria for adverse events (CTCAE).

  Until surgery at 8-10 weeks post chemoradiation (which is 13-15 weeks (control) or 14-16 weeks (boost) post randomization

• Patient reported quality of life

  at baseline and 3, 6, 12 and 24 months after treatment.

• Tumor response on Magnetic resonance imaging (MRI)

  at week 2 during chemoradiation and week 7 post chemoradiation.

• Patient reported workability

  at baseline and 3, 6, 12 and 24 months after treatment.

• Surgical complication

  untill 30 days after surgery, which is 17-19 weeks (control) or 18-20 weeks (boost) post randomization

Study Arms (2)

Boost

EXPERIMENTAL

Boost radiation consists of 5 fractions of 3 Gy (total 15 Gy) delivered to the tumor (Gross Tumor Volume) additional to standard chemoradiation of 50 Gy with Capecitabine.

Radiation: Boost

Standard chemoradiation

NO INTERVENTION

Standard chemoradiation consisting of 25 x 2 Gy (total 50 Gy) with Capecitabine.

Interventions

Boost RADIATION

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

Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant in the PLCRC project (ClinicalTrials.gov: NCT02070146)
• Informed consent obtained for being offered experimental interventions within the PLCRC project
• Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project
• WHO: 0-2
• Indication for chemoradiation based on primary tumor, regional nodes, metastasis (TNM) stage
• Referred for chemoradiation
• No contra-indication for MRI
• Tumor distance from ano-rectal transition ≤10 cm

You may not qualify if:

• \<18 years
• No indication for chemoradiation according to Dutch guidelines based on TNM staging.
• Inflammatory bowel disease
• Prior pelvic radiotherapy
• At least one contra-indication for Capecitabine administration (based on Dihydropyrimidine dehydrogenase (DPD)-deficiency, bloodcount, liver malfunction, renal failure (Creatinine clearance \<30 ml/min), medical history such as recent cardiac events
• Recent pregnancy ≤ 1 year ago
• Inadequate understanding of the Dutch language in speech and/or writing

Sponsors & Collaborators

• UMC Utrecht: lead
• Maastro Clinic, The Netherlands: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (4)

• Verweij ME, Hoendervangers S, Couwenberg AM, Burbach JPM, Berbee M, Buijsen J, Roodhart J, Reerink O, Pronk A, Consten ECJ, Smits AB, Heikens JT, van Grevenstein WHMU, Intven MPW, Verkooijen HLM. Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial. Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):694-703. doi: 10.1016/j.ijrobp.2021.09.052. Epub 2021 Oct 8.

  PMID: 34634436 DERIVED

• Couwenberg AM, Burbach JPM, Berbee M, Lacle MM, Arensman R, Raicu MG, Wessels FJ, Verdult J, Roodhart J, Reerink O, Hoendervangers S, Buijsen J, Grabsch HI, Pronk A, Consten ECJ, Smits AB, Heikens JT, Appelt AL, van Grevenstein WMU, Verkooijen HM, Intven MPW. Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1008-1018. doi: 10.1016/j.ijrobp.2020.06.013. Epub 2020 Jun 19.

  PMID: 32565319 DERIVED

• Couwenberg AM, Burbach JPM, May AM, Berbee M, Intven MPW, Verkooijen HM. The trials within cohorts design facilitated efficient patient enrollment and generalizability in oncology setting. J Clin Epidemiol. 2020 Apr;120:33-39. doi: 10.1016/j.jclinepi.2019.12.015. Epub 2019 Dec 19.

  PMID: 31866471 DERIVED

• Burbach JP, Verkooijen HM, Intven M, Kleijnen JP, Bosman ME, Raaymakers BW, van Grevenstein WM, Koopman M, Seravalli E, van Asselen B, Reerink O. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials. 2015 Feb 22;16:58. doi: 10.1186/s13063-015-0586-4.

  PMID: 25888548 DERIVED

Related Links

• The PLCRC Project

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• HM Verkooijen, MD PhD

  Imaging Division, UMC Utrecht

  PRINCIPAL INVESTIGATOR

• M. Berbee, MD PhD

  Radiation-Oncology, MAASTRO clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: cohort multiple randomized controlled trial

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 26, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

NL (1)