Trial · NCT02177695
S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
NCT02177695, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2022-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer. Trials, record NCT02177695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02177695
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
- NCT number
- NCT02177695
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 237 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Bladder Cancer
- Interventions
- Gemcitabine, Cisplatin, Methotrexate, Vinblastine, Doxorubicin, Filgrastim
- First posted
- 2014-06-30
- Last updated
- 2024-09-19
- Results first posted
- 2022-01-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Up to 5 years post registration | The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Primary | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | up to 5 years post-registration | The proportion of participants achieving \<=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved \<= pT1 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Primary | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | up to 5 years post-registration | To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC) P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or \<= pT1. Interactions with p-values \> 0.05 are interpreted as not significant. \_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Primary | Correlation Between GC-and ddMVAC-COXEN Score | up to 5 years post-registration | The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score. |
| Secondary | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post registration | In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. \*note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol. |
| Secondary | Value of Gene Expression Profiling in Predicting Overall Survival (OS) | Up to 5 years post registration | 5-year OS curve was estimated using the Kaplan-Meier method. Included all COXEN evaluable participants regardless of arm assignment. The report groups were favorable vs. unfavorable COXEN status. |
| Secondary | Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post-registration | Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 5 years post registration | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3 is less severe than Grade 5. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\* (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE \*ADL- Activities of Daily Living |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Up to 5 years post registration | Eligible participants that were evaluable for COXEN analysis | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | up to 5 years post-registration | Eligible participants that were evaluable for COXEN analysis | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | up to 5 years post-registration | Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm. | p-value | NUMBER |
| PRIMARY | Correlation Between GC-and ddMVAC-COXEN Score | up to 5 years post-registration | Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm. | correlation coefficient | NUMBER |
| SECONDARY | Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post registration | Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm. | p-value | NUMBER |
| SECONDARY | Value of Gene Expression Profiling in Predicting Overall Survival (OS) | Up to 5 years post registration | Eligible participants across both arms that were evaluable for COXEN analysis. | Percent of Participants | NUMBER |
| SECONDARY | Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC) | Up to 5 years post-registration | Participants who received treatment in Gemcitabine \& Cisplatin and Dose Dense MVAC arms. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 5 years post registration | Participants who received at least one dose of protocol treatment, submitted toxicity data and were included in the ITT analysis. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Gemcitabine & Cisplatin | Favorable treatment-COXEN score | 8 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Dose Dense MVAC | Favorable treatment-COXEN score | 10 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Gemcitabine & Cisplatin | Unfavorable treatment-COXEN score | 20 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate | Dose Dense MVAC | Unfavorable treatment-COXEN score | 17 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Gemcitabine & Cisplatin | Favorable treatment-COXEN score | 10 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Dose Dense MVAC | Favorable treatment-COXEN score | 16 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Gemcitabine & Cisplatin | Unfavorable treatment-COXEN score | 30 | Participants | |
| Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate | Dose Dense MVAC | Unfavorable treatment-COXEN score | 31 | Participants | |
| Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | All Participants | P-value of interaction term (GCscore*treatment arm) in model predicting pT0 | 0.88 | p-value | |
| Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC | All Participants | P-value of interaction term (GCscore*treatment arm) in logistic regression model predicting <=pT1 | 0.43 | p-value |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| ITT Analysis | STARTED | Gemcitabine & Cisplatin | 120 | |
| ITT Analysis | STARTED | Dose Dense MVAC | 117 | |
| ITT Analysis | COMPLETED | Gemcitabine & Cisplatin | 115 | |
| ITT Analysis | COMPLETED | Dose Dense MVAC | 112 | |
| ITT Analysis | NOT COMPLETED | Gemcitabine & Cisplatin | 5 | |
| ITT Analysis | NOT COMPLETED | Dose Dense MVAC | 5 | |
| Primary COXEN Analysis | STARTED | Gemcitabine & Cisplatin | 115 | |
| Primary COXEN Analysis | STARTED | Dose Dense MVAC | 112 | |
| Primary COXEN Analysis | Participants Excluded From Primary COXEN Analysis | Gemcitabine & Cisplatin | 33 | |
| Primary COXEN Analysis | Participants Excluded From Primary COXEN Analysis | Dose Dense MVAC | 27 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events434
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine and Cisplatin | 83 | 115 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Dense MVAC | 69 | 112 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Gemcitabine and Cisplatin | 2 | 115 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Dose Dense MVAC | 1 | 112 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Gemcitabine and Cisplatin | 2 | 115 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Dense MVAC | 1 | 112 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Gemcitabine and Cisplatin | 0 | 115 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Dense MVAC | 1 | 112 | |
| other | Atrial flutter | Cardiac disorders | Gemcitabine and Cisplatin | 0 | 115 | |
| other | Atrial flutter | Cardiac disorders | Dose Dense MVAC | 1 | 112 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine and Cisplatin | 28 | 115 |
| Total, all-cause mortality | Dose Dense MVAC | 25 | 112 |
| Total, other adverse events | Gemcitabine and Cisplatin | 112 | 115 |
| Total, other adverse events | Dose Dense MVAC | 108 | 112 |
| Total, serious adverse events | Gemcitabine and Cisplatin | 1 | 115 |
| Total, serious adverse events | Dose Dense MVAC | 4 | 112 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gemcitabine and Cisplatin vs Dose Dense MVAC: deaths from any cause | Trial comparisons |
| Gemcitabine and Cisplatin vs Dose Dense MVAC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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