Trial · NCT02106884
Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
NCT02106884, Phase 2, Completed, Universitaire Ziekenhuizen KU Leuven; results first posted 2019-10-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel. Trials, record NCT02106884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106884
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
- NCT number
- NCT02106884
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Pancreatic Cancer
- Interventions
- Nab-paclitaxel, Gemcitabine
- First posted
- 2014-04-08
- Last updated
- 2019-11-06
- Other registries' IDs
- eudract:2013-004101-75
- Results first posted
- 2019-10-24
- Limitations and caveats
Quality of life endpoints are sensitive to confounding factors such as age, intercurrent disease, time from last completed questionnaire to the last follow-up or death. Tumour response and AE relationship to treatment were locally adressed.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | From date of randomisation to 3, 6 and 12 months respectively | The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?". Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up. |
| Primary | QOL Global Health Status Deterioration-free Median Survival | From date of randomisation to end of follow up (max 3 years after database lock when applicable). | The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up. |
| Secondary | Overall Response | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response (OR) is defined as the best tumor response on treatment for each patient. Responders were considered CR + PR. Some patients were not evaluable for response (no scans available). Overall response rates (ORR) were calculated based on the ITT set. |
| Secondary | Duration of Response (in Responders) | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | Duration of response was calculated from the date of first documented response to the date of progression (including SD after PR) or date of start of new treatment in not progressed, when available. In 2 patients with CR, periods of PR are included. For those not documented as progressed before death, an unknown duration was kept and considered missing data. |
| Secondary | Disease Control | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response is defined as the best tumor response on treatment for each patient. Disease control is defined as a best response on treatment of either CR, PR or SD (CR + PR + SD). Some patients were not evaluable for response (no scans available). Overall response rates were calculated based on the ITT set. |
| Secondary | Progression Free Survival | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT). |
| Secondary | Overall Survival | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | Overall survival was considered from start of treatment to death. All patients (ITT) |
| Secondary | Laboratory Safety Assessment | Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient. | Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set). |
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 | Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | From date of randomisation to 3, 6 and 12 months respectively | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | percentage of participants | NUMBER |
| PRIMARY | QOL Global Health Status Deterioration-free Median Survival | From date of randomisation to end of follow up (max 3 years after database lock when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Months | MEDIAN |
| SECONDARY | Overall Response | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (in Responders) | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Months | MEDIAN |
| SECONDARY | Disease Control | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Months | MEDIAN |
| SECONDARY | Overall Survival | Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable). | ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal. | Months | MEDIAN |
| SECONDARY | Laboratory Safety Assessment | Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient. | All pts treated (safety set). Analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses in treatment switchers will be published in a peer reviewed journal. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm A (Nab-Paclitaxel + Gemcitabine) | Rate at 3 months (percentage) | 89 | percentage of participants | |
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm B (Gemcitabine) | Rate at 3 months (percentage) | 73 | percentage of participants | |
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm A (Nab-Paclitaxel + Gemcitabine) | Rate at 6 months (percentage) | 74 | percentage of participants | |
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm B (Gemcitabine) | Rate at 6 months (percentage) | 59 | percentage of participants | |
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm A (Nab-Paclitaxel + Gemcitabine) | Rate at 12 months (percentage) | 40 | percentage of participants | |
| Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) | Arm B (Gemcitabine) | Rate at 12 months (percentage) | 35 | percentage of participants | |
| QOL Global Health Status Deterioration-free Median Survival | Arm A (Nab-Paclitaxel +Gemcitabine) | 10.04 | 95% Confidence Interval 7.16 to 12.02 | Months | |
| QOL Global Health Status Deterioration-free Median Survival | Arm B (Gemcitabine) | 8.02 | 95% Confidence Interval 5.49 to 11.37 | Months | |
| Overall Response | Arm A (Nab-Paclitaxel + Gemcitabine) | CR or PR | 31 | Participants | |
| Overall Response | Arm B (Gemcitabine) | CR or PR | 16 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Nab-Paclitaxel + Gemcitabine) | 72 | |
| Overall Study | STARTED | Arm B (Gemcitabine) | 74 | |
| Overall Study | COMPLETED | Arm A (Nab-Paclitaxel + Gemcitabine) | 72 | |
| Overall Study | COMPLETED | Arm B (Gemcitabine) | 73 | |
| Overall Study | NOT COMPLETED | Arm A (Nab-Paclitaxel + Gemcitabine) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Gemcitabine) | 1 |
Source ClinicalTrials.gov
Adverse events328
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 | Capillary leak syndrome | Vascular disorders | Arm A (Nab-Paclitaxel + Gemcitabine) | 0 | 72 | 0 |
| other | Capillary leak syndrome | Vascular disorders | Arm B (Gemcitabine) | 1 | 74 | 1 |
| other | Hematoma | Vascular disorders | Arm A (Nab-Paclitaxel + Gemcitabine) | 0 | 72 | 0 |
| other | Hematoma | Vascular disorders | Arm B (Gemcitabine) | 1 | 74 | 1 |
| other | Hypertension | Vascular disorders | Arm A (Nab-Paclitaxel + Gemcitabine) | 8 | 72 | 12 |
| other | Hypertension | Vascular disorders | Arm B (Gemcitabine) | 7 | 74 | 11 |
| other | Thromboembolic event | Vascular disorders | Arm A (Nab-Paclitaxel + Gemcitabine) | 5 | 72 | 6 |
| other | Thromboembolic event | Vascular disorders | Arm B (Gemcitabine) | 6 | 74 | 8 |
| other | Hypotension | Vascular disorders | Arm A (Nab-Paclitaxel + Gemcitabine) | 0 | 72 | 0 |
| other | Hypotension | Vascular disorders | Arm B (Gemcitabine) | 1 | 74 | 1 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Nab-Paclitaxel + Gemcitabine) | 5 | 72 |
| Total, all-cause mortality | Arm B (Gemcitabine) | 11 | 74 |
| Total, other adverse events | Arm A (Nab-Paclitaxel + Gemcitabine) | 72 | 72 |
| Total, other adverse events | Arm B (Gemcitabine) | 74 | 74 |
| Total, serious adverse events | Arm A (Nab-Paclitaxel + Gemcitabine) | 50 | 72 |
| Total, serious adverse events | Arm B (Gemcitabine) | 48 | 74 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Nab-Paclitaxel + Gemcitabine) vs Arm B (Gemcitabine): deaths from any cause | Trial comparisons |
| Arm A (Nab-Paclitaxel + Gemcitabine) vs Arm B (Gemcitabine): 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02106884
GET https://conductscience.org/api/trials/v1/NCT02106884/results?page=2