Trial Outcomes & Findings for Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery (NCT NCT00833859)
NCT ID: NCT00833859
Last Updated: 2017-10-09
Results Overview
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
TERMINATED
PHASE2
2 participants
6 months per patient
2017-10-09
Participant Flow
Participant milestones
| Measure |
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
Baseline characteristics by cohort
| Measure |
Chemotherapy Followed by Radiation Treatment
n=2 Participants
Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 months per patientPopulation: Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months per patientPopulation: Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.
Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months per patientPopulation: Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.
Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months per patientPopulation: Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.
We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy Followed by Radiation Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chemotherapy Followed by Radiation Treatment
n=2 participants at risk
Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
2/2 • Number of events 5 • 6 months
|
|
Cardiac disorders
Intermittent hypotension
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pale skin
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Itchy rash
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
100.0%
2/2 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
1/2 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Dizziness/lightheadedness
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Presyncope
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Chest tightness
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
50.0%
1/2 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Increased fatigue
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Insomia
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cracks on lips
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cracks on feet
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Red peeling spots on arms
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Dehydration
|
50.0%
1/2 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Yellow stools
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Hemorrhoid
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Malabsorption
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Mouth sores
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Intermittent nausea
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Taste alteration
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Calf tightness
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Sort throat/redness
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes (raspy)
|
50.0%
1/2 • Number of events 1 • 6 months
|
Additional Information
Gregory Springett, M.D., Ph.D., via Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place