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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000616858 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer that was removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to tumor stage (T2 vs T3-4a). Patients are randomized to 1 of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-FU and Cisplatin + BID Irradiation | Experimental | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
|
| Gemcitabine + QD Irradiation | Experimental | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| induction cisplatin | Drug | 15 mg/m^2 administered as a 60-minute infusion on days 1,2,3,8,9,10,15,16,17. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Without Distant Metastases by Three Years | Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone. | From randomization to three years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Completed Treatment Per Protocol | Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol. | After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges. |
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Inclusion criteria:
Pathologically (histologically or cytologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are American Joint Committee on Cancer (AJCC) clinical stages T2-T4a, Nx or N0, M0 (Appendix IV) without hydronephrosis; patients who have involvement of the prostatic urethra with transitional cell cancer (TCC) that was visibly completely resected and no evidence of stromal invasion of the prostate remain eligible. T2a, T2b, T3a, T3b -substages‖ are not usually able to be determined with clinical (TURBT) staging.
If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist.
History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration
Zubrod Performance Status ≤ 1
Age ≥ 18
Complete blood count (CBC)/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater no more than 4 weeks prior to registration; Note: Calculated creatinine clearance is permissible. If the creatinine clearance is > 60 ml/min, then a serum creatinine of up to 1.8 mg% is allowable at the discretion of the study chair;
Serum pregnancy test for female patients of childbearing potential, ≤ 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion criteria:
Evidence of tumor-related hydronephrosis
Evidence of distant metastases or histologically or cytologically proven lymph node metastases
Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
Patients judged not to be candidates for radical cystectomy; patients with pN+ or T4b disease are considered to have unresectable disease
Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
Severe, active co-morbidity, defined as follows:
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Prior allergic reaction to the study drug(s) involved in this protocol
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| Name | Affiliation | Role |
|---|---|---|
| John J. Coen, MD | GenesisCare USA | Principal Investigator |
| Philip J. Saylor, MD | Massachusetts General Hospital | Study Chair |
| Cheryl T. Lee, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Chin-Lee Wu, MD, PhD | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205754 | Result | Choudhury A, Swindell R, Logue JP, Elliott PA, Livsey JE, Wise M, Symonds P, Wylie JP, Ramani V, Sangar V, Lyons J, Bottomley I, McCaul D, Clarke NW, Kiltie AE, Cowan RA. Phase II study of conformal hypofractionated radiotherapy with concurrent gemcitabine in muscle-invasive bladder cancer. J Clin Oncol. 2011 Feb 20;29(6):733-8. doi: 10.1200/JCO.2010.31.5721. Epub 2011 Jan 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-FU and Cisplatin + BID Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID [twice daily] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 18, 2014 |
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| induction 5-fluorouracil | Drug | 400mg/m^2 administered as a 24-hour infusion on days 1,2,3, and 15,16,17. |
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| induction gemcitabine | Drug | 27 mg/m^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15, 18, 22, 25. |
|
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| Induction BID radiation therapy | Radiation | Twice daily (BID) on days 1-5,8-12,15-17. The first daily treatment consists of 1.6 Gy delivered to the pelvis. The second fraction consists of 1.5 Gy to the bladder for the first 5 treatment days. Then, 1.5 Gy is delivered to bladder tumor volume as the second treatment for the remaining 8 treatment days. The bladder tumor volume receives a total of 40.3 Gy. |
|
| Induction QD radiation therapy | Radiation | Once daily (QD) on days (1-5,8-12,15-19,22-26). For the first 10 treatment days, 2 Gy is delivered to the pelvis. Then, 2 Gy is delivered to the bladder for the next 4 treatment days, followed by 2 Gy to the bladder tumor volume for the remaining 6 treatment days. The bladder tumor volume receives a total of 40 Gy. |
|
| Consolidation BID radiation therapy | Radiation | Twice daily (BID) for 8 days on days 1,2,3,4,5,8,9,10 of consolidation. 1.5 Gy per fraction for a total of 24 Gy delivered to the pelvis. |
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| Consolidation QD radiation therapy | Radiation | Once daily (QD) pelvic radiation therapy for 12 days on days 1-5,8-12,15-16 of consolidation. 2 Gy per fraction for a total of 24 Gy delivered to the pelvis. |
|
| consolidation gemcitabine | Drug | 27 mg/m^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15 of consolidation. |
|
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| consolidation 5-fluorouracil | Drug | 400 mg/m^2 administered as a 24-hour infusion on days 1, 2, 3 and 8, 9, 10 of consolidation. |
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| consolidation cisplatin | Drug | 15 mg/m^2 administered as a sixty-minute infusion on days 1, 2, 8, 9 of consolidation. |
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| radical cystectomy | Procedure | Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation. |
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| Post-Induction Chemoradiotherapy Endoscopic Response Evaluation | Procedure | Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy. |
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| adjuvant gemcitabine | Drug | 1000 mg/m^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles. |
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| adjuvant cisplatin | Drug | 70 mg/m^2 administered as a sixty-minute infusion on day 1 of each 21-day cycle for four cycles. |
|
| Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events | Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment. | From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges. |
| Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy | Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s). | 3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows) |
| Number of Participants With Progression or Removal of Bladder Five Years After Therapy | Progression is defined as an increase of 50% or more in the largest diameter of the endoscopically appreciable tumor in the tumor-site biopsy specimen, the development of new bladder tumors, or the development of metastatic disease. | From start of treatment to five years after the end of therapy. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges. |
| Change in American Urological Association Symptom Index (AUASI) Score at 3 Years | The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement. | Baseline and 3 years |
| Determining Potentially Predictive Biomarkers for Acute and Late Toxicities | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out |
| Determining Potentially Predictive Biomarkers for Cystectomy-free Survival | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out |
| Winship Cancer Institute of Emory University |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Parkview Regional Cancer Center at Parkview Health | Fort Wayne | Indiana | 46805 | United States |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | United States |
| Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River | Massachusetts | 02721 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| FG001 | Gemcitabine + QD Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD [once a day] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
| Eligible |
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| Has 3-year Efficacy Data | Eligible and has 3-year distant metastasis status |
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| Started Induction Therapy | Eligible and started induction therapy |
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| Started Consolidation Therapy | Eligible and started consolidation therapy |
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| Started Adjuvant Therapy | Eligible and started adjuvant therapy |
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| Has Adverse Event Data (Treatment) | Eligible and has adverse event data during treatment |
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| Has Adverse Event Data (Late) | Eligible and has adverse event data between end of treatment to 180 days after end of treatment |
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| Has 3 Year AUASI Data | Eligible and has baseline and 3-year American Urological Association Symptom Index (AUASI) scores |
|
| COMPLETED | Subjects contributing any data to analysis are considered to have completed the study |
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| NOT COMPLETED |
|
|
Eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-FU and Cisplatin + BID Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
| BG001 | Gemcitabine + QD Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Zubrod Performance Status | Measure Description: 0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, <50% in bed during the day; 3 - Symptomatic, >50% in bed, but not bedbound; 4 - Bedbound; 5 - Death | Count of Participants | Participants |
| ||||||||||||||||||
| T Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Without Distant Metastases by Three Years | Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone. | Eligible patients with 3-year data | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization to three years |
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| Secondary | Percentage of Patients Who Completed Treatment Per Protocol | Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol. | Eligible patients who started each treatment component (induction, consolidation, adjuvant) | Posted | Count of Participants | Participants | After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges. |
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| Secondary | Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events | Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment. | Eligible patients with adverse event data for corresponding time period | Posted | Count of Participants | Participants | From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges. |
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| Secondary | Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy | Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s). | Eligible patients who started induction therapy | Posted | Count of Participants | Participants | 3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows) |
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| Secondary | Number of Participants With Progression or Removal of Bladder Five Years After Therapy | Progression is defined as an increase of 50% or more in the largest diameter of the endoscopically appreciable tumor in the tumor-site biopsy specimen, the development of new bladder tumors, or the development of metastatic disease. | Eligible participants with five-year data | Posted | Count of Participants | Participants | From start of treatment to five years after the end of therapy. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges. |
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| Secondary | Change in American Urological Association Symptom Index (AUASI) Score at 3 Years | The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement. | Eligible patients with baseline and 3-year scores | Posted | Median | Full Range | units on a scale | Baseline and 3 years |
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| Secondary | Determining Potentially Predictive Biomarkers for Acute and Late Toxicities | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from our tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | Posted | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out |
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| Secondary | Determining Potentially Predictive Biomarkers for Cystectomy-free Survival | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from our tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | Posted | The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out |
|
From randomization to last follow-up. Maximum follow-up was 11.4 years.
Adverse event population = eligible patients who started protocol treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients receive induction therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 8-10. | 16 | 33 | 11 | 33 | 33 | 33 |
| EG001 | Arm II | Patients receive induction therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 8-10. | 11 | 33 | 8 | 33 | 33 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [other] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Catheter related infection [with Grade 3-4 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection [other] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intraoperative complications | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| General symptom | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Irritability | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [other] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intraoperative complications | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| INR increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Adverse event data was updated when outcome measure 5 was entered.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Jul 1, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D015653 | Cystectomy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 60-69 years |
|
| >= 70 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| cT3-T4a |
|
If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen. |
|
|
| OG001 | Gemcitabine + QD Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
|
|
|
|
|
Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
|
|
|
| OG001 | Gemcitabine + QD Irradiation | Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
|
|
Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
|
Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks. |
|