TY - JOUR
T1 - RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study)
T2 - study protocol for a randomized controlled trial
AU - Burbach, J. P. Maarten
AU - Verkooijen, Helena M.
AU - Intven, Martijn
AU - Kleijnen, Jean-Paul J. E.
AU - Bosman, Mirjam E.
AU - Raaymakers, Bas W.
AU - van Grevenstein, Wilhelmina M. U.
AU - Koopman, Miriam
AU - Seravalli, Enrica
AU - van Asselen, B
AU - Reerink, Onne
PY - 2015/2/22
Y1 - 2015/2/22
N2 - Background: Treatment for locally advanced rectal cancer (LARC) consists of chemoradiation therapy (CRT) and surgery. Approximately 15% of patients show a pathological complete response (pCR). Increased pCR-rates can be achieved through dose escalation, thereby increasing the number patients eligible for organ-preservation to improve quality of life (QoL). A randomized comparison of 65 versus 50Gy with external-beam radiation alone has not yet been performed. This trial investigates pCR rate, clinical response, toxicity, QoL and (disease-free) survival in LARC patients treated with 65Gy (boost + chemoradiation) compared with 50Gy standard chemoradiation (sCRT).Methods/design: This study follows the 'cohort multiple randomized controlled trial' (cmRCT) design: rectal cancer patients are included in a prospective cohort that registers clinical baseline, follow-up, survival and QoL data. At enrollment, patients are asked consent to offer them experimental interventions in the future. Eligible patients-histologically confirmed LARC (T3NxM0Discussion: The boost is delivered prior to sCRT so that GTV adjustment for tumor shrinkage during sCRT is not necessary. Small margins also aim to limit irradiation of healthy tissue. The cmRCT design provides opportunity to overcome common shortcomings of classic RCTs, such as slow recruitment, disappointment-bias in control arm patients and poor generalizability.
AB - Background: Treatment for locally advanced rectal cancer (LARC) consists of chemoradiation therapy (CRT) and surgery. Approximately 15% of patients show a pathological complete response (pCR). Increased pCR-rates can be achieved through dose escalation, thereby increasing the number patients eligible for organ-preservation to improve quality of life (QoL). A randomized comparison of 65 versus 50Gy with external-beam radiation alone has not yet been performed. This trial investigates pCR rate, clinical response, toxicity, QoL and (disease-free) survival in LARC patients treated with 65Gy (boost + chemoradiation) compared with 50Gy standard chemoradiation (sCRT).Methods/design: This study follows the 'cohort multiple randomized controlled trial' (cmRCT) design: rectal cancer patients are included in a prospective cohort that registers clinical baseline, follow-up, survival and QoL data. At enrollment, patients are asked consent to offer them experimental interventions in the future. Eligible patients-histologically confirmed LARC (T3NxM0Discussion: The boost is delivered prior to sCRT so that GTV adjustment for tumor shrinkage during sCRT is not necessary. Small margins also aim to limit irradiation of healthy tissue. The cmRCT design provides opportunity to overcome common shortcomings of classic RCTs, such as slow recruitment, disappointment-bias in control arm patients and poor generalizability.
KW - QUALITY-OF-LIFE
KW - COMPLETE CLINICAL-RESPONSE
KW - PATHOLOGICAL RESPONSE
KW - CHEMORADIATION THERAPY
KW - COLORECTAL-CANCER
KW - CHEMORADIOTHERAPY
KW - RADIOTHERAPY
KW - METAANALYSIS
KW - RECURRENCE
KW - EXCISION
U2 - 10.1186/s13063-015-0586-4
DO - 10.1186/s13063-015-0586-4
M3 - Article
C2 - 25888548
SN - 1745-6215
VL - 16
JO - Trials [E]
JF - Trials [E]
M1 - 58
ER -