Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686149
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-12-28
First Post:
2020-12-24
Brief Title:
a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Development of a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation After Preoperative Chemoradiotherapy in Muscle Invasive Bladder Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection but 50 of patients experience recurrence within 2 years after surgery The recurrence after surgery is associate with T3 stage the presence of invading soft tissue around the bladder and N1 lymph node metastasis Therefore various methods are being tried to reduce recurrence and metastasis among which preoperative chemotherapy has been reported to increase survival rate Based on this preoperative chemotherapy followed by radical cystectomy are also recommended However there are several limitations The surgery may be delayed in case of non-responsive to chemotherapy the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer Therefore the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival However after radical cystectomy there is discomfort for patients regarding the removal of the bladder Treating the bladder while preserving the bladder is getting its attention The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor The bladder preserving treatment is performed in patients who have unresectable locally advanced bladder cancer or are not medically appropriate for surgery The 5-year overall survival is reported to be around 50-60 To date no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions Therefore in order to perform the bladder preserving treatment a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed Responsiveness to radiotherapy is a combination of various factors and radiation sensitivity of tumors is the most important The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data In this study we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information
Detailed Description:
The treatment in this study is one of the standard treatments suggested by the NCCN guidelines Bladder is preserved when neoadjuvant concurrent chemoradiotherapy is performed after transurethral resection of bladder tumor and complete remission is achieved through the cystoscopy If complete response is not achieved additional chemotherapy is performed In case that complete response is not achieved through the cystoscopy after additional chemotherapy cystectomy is performed If complete response is achieved the bladder is preserved
Before treatment the following are obtained Medical history and physical examination Tissue acquisition through transurethral resection of bladder tumor Blood Test CBC Chemistry Test SMA staging through pelvic CT or MRI cystoscopy PET-CT or chest CT
Cisplatin based concurrent chemoradiotherapy is conducted 4 times during the radiotherapy AFter radiotherapy the gemcitabinecisplatin or gemcitabinecarboplatin treatment is performed The target delineation is performed in 3mm simulation CT for radiotherapy To consider the uncertainty of breath the 4D CT is taken GTV includes primary lesions and lymph node based on diagnostic CT MRI and PET-CT CTV covers the entire bladder with microscopic margin of GTV PTV1 is defined as extending 15cm from the entire bladder PTV2 is defined as extending 15cm from GTV Radiotherapy is performed using 3D conformal radiotherapy intensity-modulated radiotherapy volumetric modulated Arc therapy Radiotherapy is administered daily five times a week according to the NCCN guidelines Each treatment is performed with bladder empty radiotherapy is performed 20 fractions in total For the first 15 fractions 265Gy administered for PTV1 including the entire bladder For rest 5 fractions 3 Gy for PTV2 is administered Totally 55 Gy is administered
If complete response is not achieved the surgery and timing of surgery are determined by the urologist according to the location and severity of the primary cancer The biopsy if performed using cystoscopy If the findings are complete response no additional treatment is performed and if not radical cystectomy is performed
The treatment response is evaluated based on standard treatment process During the treatment the regular check up is conducted to evaluate the acute toxicity regarding treatment After bladder preserving treatment the pelvic CT MRI and cystoscopy is used for evaluation
The acquired specimens are used for RNA sequencing and organoid construction The RNA sequencing is used to analyze the differentially expressed based on treatment response to neoadjuvant concurrent chemoradiotherapy
Before treatment the following are obtained Medical history and physical examination Tissue acquisition through transurethral resection of bladder tumor Blood Test CBC Chemistry Test SMA staging through pelvic CT or MRI cystoscopy PET-CT or chest CT
Cisplatin based concurrent chemoradiotherapy is conducted 4 times during the radiotherapy AFter radiotherapy the gemcitabinecisplatin or gemcitabinecarboplatin treatment is performed The target delineation is performed in 3mm simulation CT for radiotherapy To consider the uncertainty of breath the 4D CT is taken GTV includes primary lesions and lymph node based on diagnostic CT MRI and PET-CT CTV covers the entire bladder with microscopic margin of GTV PTV1 is defined as extending 15cm from the entire bladder PTV2 is defined as extending 15cm from GTV Radiotherapy is performed using 3D conformal radiotherapy intensity-modulated radiotherapy volumetric modulated Arc therapy Radiotherapy is administered daily five times a week according to the NCCN guidelines Each treatment is performed with bladder empty radiotherapy is performed 20 fractions in total For the first 15 fractions 265Gy administered for PTV1 including the entire bladder For rest 5 fractions 3 Gy for PTV2 is administered Totally 55 Gy is administered
If complete response is not achieved the surgery and timing of surgery are determined by the urologist according to the location and severity of the primary cancer The biopsy if performed using cystoscopy If the findings are complete response no additional treatment is performed and if not radical cystectomy is performed
The treatment response is evaluated based on standard treatment process During the treatment the regular check up is conducted to evaluate the acute toxicity regarding treatment After bladder preserving treatment the pelvic CT MRI and cystoscopy is used for evaluation
The acquired specimens are used for RNA sequencing and organoid construction The RNA sequencing is used to analyze the differentially expressed based on treatment response to neoadjuvant concurrent chemoradiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None