Trial Outcomes & Findings for A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer (NCT NCT01495676)
NCT ID: NCT01495676
Last Updated: 2025-10-10
Results Overview
The time to relapse is defined as the time from the date of randomisation to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. Patients without relapse and living at 2 years will be considered a success
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Two years after the end of the complete therapeutic sequence
Results posted on
2025-10-10
Participant Flow
Participant milestones
| Measure |
Radiotherapy + Cisplatin
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
45
|
|
Overall Study
COMPLETED
|
24
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Radiotherapy + Cisplatin
n=24 Participants
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=45 Participants
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.5 years
n=24 Participants
|
71 years
n=45 Participants
|
72 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=24 Participants
|
6 Participants
n=45 Participants
|
8 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=24 Participants
|
39 Participants
n=45 Participants
|
61 Participants
n=69 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Two years after the end of the complete therapeutic sequenceThe time to relapse is defined as the time from the date of randomisation to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. Patients without relapse and living at 2 years will be considered a success
Outcome measures
| Measure |
Radiotherapy + Cisplatin
n=24 Participants
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=45 Participants
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
Patients Without Severe Late Toxicity
patient with late severe toxicity
|
Patients With Severe Toxicity (Acute and Late)
patient with acute and late severe toxicity
|
|---|---|---|---|---|
|
Disease-free Survival
Number of patients without any event (local, regional, distance, or death)
|
11 Participants
|
22 Participants
|
—
|
—
|
|
Disease-free Survival
Number of patients with any event (local, regional, distance, or death)
|
13 Participants
|
23 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe time to death is defined as time from the randomization to the date of death from any cause, or to the date on which latest information is obtained.
Outcome measures
| Measure |
Radiotherapy + Cisplatin
n=24 Participants
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=45 Participants
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
Patients Without Severe Late Toxicity
patient with late severe toxicity
|
Patients With Severe Toxicity (Acute and Late)
patient with acute and late severe toxicity
|
|---|---|---|---|---|
|
Overall Survival
number of patient alive
|
17 Participants
|
25 Participants
|
—
|
—
|
|
Overall Survival
number of patient death
|
7 Participants
|
20 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analyses are performed on the population that can be evaluated for tolerance
Acute and late toxicities will be scored according to the NCI-CTC v4.0. Grade 0 : no toxicity Grade 4 : worse toxicity
Outcome measures
| Measure |
Radiotherapy + Cisplatin
n=24 Participants
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=43 Participants
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
Patients Without Severe Late Toxicity
patient with late severe toxicity
|
Patients With Severe Toxicity (Acute and Late)
patient with acute and late severe toxicity
|
|---|---|---|---|---|
|
Acute and Late Toxicities
late toxicity per patient · grade < 3
|
21 Participants
|
40 Participants
|
—
|
—
|
|
Acute and Late Toxicities
late toxicity per patient · grade 3/4
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Acute and Late Toxicities
acute toxicity per patient · grade < 3
|
21 Participants
|
20 Participants
|
—
|
—
|
|
Acute and Late Toxicities
acute toxicity per patient · grade 3/4
|
3 Participants
|
23 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: patient groups were defined in order to validate a possible correlation between the apoptosis rate observed during blood analysis and the severe toxicity rate.
Before starting radiotherapy, 5ml of blood will be sampled in a 5ml heparinised tube to prospectively measure the rate of CD8 radio-induced lymphocyte apoptosis before any radiotherapy treatment. A correlation between the low rate of lymphocyte apoptosis and the severity of late toxicities will be studied to confirm the predictive power of this biological test on radio-induced side-effects. Percentage of Cell Death Measured by Apoptosis This Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention
Outcome measures
| Measure |
Radiotherapy + Cisplatin
n=7 Participants
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=10 Participants
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
Patients Without Severe Late Toxicity
n=2 Participants
patient with late severe toxicity
|
Patients With Severe Toxicity (Acute and Late)
n=2 Participants
patient with acute and late severe toxicity
|
|---|---|---|---|---|
|
Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities.
Apoptosis CD8 spontaneous
|
2.9 Percentage of dead Cells
Standard Deviation 1.4
|
2.7 Percentage of dead Cells
Standard Deviation 1.4
|
3.4 Percentage of dead Cells
Standard Deviation 1.4
|
2.9 Percentage of dead Cells
Standard Deviation 0.4
|
|
Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities.
Radio-induced CD8 apoptosis
|
18 Percentage of dead Cells
Standard Deviation 10.7
|
28.2 Percentage of dead Cells
Standard Deviation 15.91
|
24.9 Percentage of dead Cells
Standard Deviation 11.9
|
23.4 Percentage of dead Cells
Standard Deviation 6
|
|
Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities.
Apoptosis CD8 to 8 Gy
|
20.9 Percentage of dead Cells
Standard Deviation 11.6
|
30.9 Percentage of dead Cells
Standard Deviation 16.6
|
28.3 Percentage of dead Cells
Standard Deviation 13.4
|
26.3 Percentage of dead Cells
Standard Deviation 6.4
|
Adverse Events
Radiotherapy + Cisplatin
Serious events: 9 serious events
Other events: 24 other events
Deaths: 7 deaths
Radiotherapy + Cisplatin + Gemcitabine
Serious events: 23 serious events
Other events: 45 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Radiotherapy + Cisplatin
n=24 participants at risk
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=45 participants at risk
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
|---|---|---|
|
Cardiac disorders
atrial flutter
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
hematuria
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Blood and lymphatic system disorders
thrombopenia
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
6.7%
3/45 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
intestinal obstruction
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
large instestinal stenosis
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
small instestinal obtstruction
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
General disorders
asthenia
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Injury, poisoning and procedural complications
radiation proctitis
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Injury, poisoning and procedural complications
gastroenteritis radiation
|
8.3%
2/24 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Infections and infestations
sepsis
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acute myeloid leukaemia
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Infections and infestations
streptococcal sepsis
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma of colon
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
glioblastoma
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lip squamous cell carcinoma
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
plasma cell myeloma
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Psychiatric disorders
completed suicide
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Vascular disorders
hypertension
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
Other adverse events
| Measure |
Radiotherapy + Cisplatin
n=24 participants at risk
Radiation + cisplatin: RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
* In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
* In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
|
Radiotherapy + Cisplatin + Gemcitabine
n=45 participants at risk
Radiation + cisplatin + gemcitabine: Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
|
|---|---|---|
|
General disorders
alopecia
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
anorexia
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
31.1%
14/45 • Number of events 14 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
General disorders
Asthenia
|
62.5%
15/24 • Number of events 15 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
60.0%
27/45 • Number of events 27 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
General disorders
Other toxicity
|
83.3%
20/24 • Number of events 20 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
88.9%
40/45 • Number of events 40 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
Diarrhea
|
54.2%
13/24 • Number of events 13 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
55.6%
25/45 • Number of events 25 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
3/24 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
26.7%
12/45 • Number of events 12 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
General disorders
dysgueusia
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
8.9%
4/45 • Number of events 4 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
2.2%
1/45 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
dysuria
|
25.0%
6/24 • Number of events 6 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
35.6%
16/45 • Number of events 16 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Infections and infestations
fever
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
6.7%
3/45 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
hematuria
|
20.8%
5/24 • Number of events 5 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
11.1%
5/45 • Number of events 5 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Infections and infestations
infection
|
0.00%
0/24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Infections and infestations
urinary infection
|
58.3%
14/24 • Number of events 14 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
53.3%
24/45 • Number of events 24 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Skin and subcutaneous tissue disorders
mucocitis
|
12.5%
3/24 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
0.00%
0/45 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
nausea
|
33.3%
8/24 • Number of events 8 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
51.1%
23/45 • Number of events 23 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Nervous system disorders
neuropathy
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
4.4%
2/45 • Number of events 2 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Renal and urinary disorders
pollakiuria
|
70.8%
17/24 • Number of events 17 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
57.8%
26/45 • Number of events 26 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Ear and labyrinth disorders
audition toxicity
|
4.2%
1/24 • Number of events 1 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
6.7%
3/45 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
|
Gastrointestinal disorders
vomiting
|
12.5%
3/24 • Number of events 3 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
11.1%
5/45 • Number of events 5 • collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated. only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
|
Additional Information
Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
INSTITUT REGIONAL DU CANCER DE MONTPELLIER
Phone: 0467613102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place