TY  - JOUR
A1  - Schmid, Sebastian C.
A1  - Koll, Florestan J.
A1  - Rödel, Claus
A1  - Maisch, Philipp
A1  - Sauter, Andreas
A1  - Beckert, Franziska
A1  - Seitz, Anna
A1  - Kübler, Hubert
A1  - Flentje, Michael
A1  - Chun, Felix
A1  - Combs, Stephanie
A1  - Schiller, Kilian
A1  - Gschwend, Jürgen E.
A1  - Retz, Margitta
T1  - Radiation therapy before radical cystectomy combined with immunotherapy in locally advanced bladder cancer – study protocol of a prospective, single arm, multicenter phase II trial (RACE IT)
T2  - BMC cancer
N2  - Background: Patients with locally advanced bladder cancer (cT3/4 cN0/N+ cM0) have a poor prognosis despite radical surgical therapy and perioperative chemotherapy. Preliminary data suggest that the combination of radiation and immunotherapy does not lead to excess toxicity and may have synergistic (abscopal) anti-tumor effects. We hypothesize that the combined preoperative application of the PD-1 checkpoint-inhibitor Nivolumab with concomitant radiation therapy of the bladder and pelvic region followed by radical cystectomy with standardized lymphadenectomy is safe and feasible and might improve outcome for patients with locally advanced bladder cancer.
Methods: Study design: “RACE IT” (AUO AB 65/18) is an investigator initiated, prospective, multicenter, open, single arm phase II trial sponsored by Technical University Munich. Study drug and funding are provided by the company Bristol-Myers Squibb.
Study treatment: Patients will receive Nivolumab 240 mg i.v. every 2 weeks for 4 cycles preoperatively with concomitant radiation therapy of bladder and pelvic region (max. 50.4 Gy). Radical cystectomy with standardized bilateral pelvic lymphadenectomy will be performed between week 11–15.
Primary endpoint: Rate of patients with completed treatment consisting of radio-immunotherapy and radical cystectomy at the end of week 15.
Secondary endpoints: Acute and late toxicity, therapy response and survival (1 year follow up).
Main inclusion criteria: Patients with histologically confirmed, locally advanced bladder cancer (cT3/4, cN0/N+), who are ineligible for neoadjuvant, cisplatin-based chemotherapy or who refuse neoadjuvant chemotherapy.
Main exclusion criteria: Patients with metastatic disease (lymph node metastasis outside pelvis or distant metastasis) or previous chemo-, immune- or radiation therapy.
Planned sample size: 33 patients, interim analysis after 11 patients.
KW  - Bladder cancer
KW  - Urothelial cancer
KW  - Transitional cell carcinoma
KW  - Locally advanced
KW  - Immunotherapy
KW  - Radiotherapy
KW  - Radical cystectomy
KW  - Nivolumab
KW  - Checkpoint inhibitor
KW  - PD-1 inhibitor
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53316
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-533168
SN  - 1471-2407
N1  - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
VL  - 20
IS  - 1, Art. 8
SP  - 1
EP  - 9
PB  - BioMed Central ; Springer
CY  - London ; Berlin ; Heidelberg
ER  -