Clinical trial · Interventional
RECTAL BOOST Study
RandomizEd Controlled Trial for Pre-operAtive Dose-escaLation BOOST in Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Boost
- description
- 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.
- interventionNames
- Radiation: Boost
- type
- NO_INTERVENTION
- label
- Standard chemoradiation
- description
- Standard chemoradiation consisting of 25 x 2 Gy (total 50 Gy) with Capecitabine.
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * 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 Exclusion criteria * \<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
References
Publications (4)
- DERIVEDVerweij 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
- DERIVEDCouwenberg 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
- DERIVEDCouwenberg 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
- DERIVEDBurbach 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