Clinical trialPhase 2Terminated
GTX-RT in Borderline Resectable Pancreatic Cancer
Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)
- Outcome
- Stopped earlyLack of pre-treatment tissue to make the study plan feasible. (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- February 2013
- Expected end
- October 2014
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- Margin-negative (R0) Resection Rate
- Sponsor
- Other
- Results posted
- 2015-08-13
- Last update
- 13 August 2015
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.
Detailed description public domain (ClinicalTrials.gov)
Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Margin-negative (R0) Resection Rate [Up to 3 years]. Number, percentage of participants. Chemotherapy Followed by Radiation Treatment (n=3): 67.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival (PFS) at Three Years [3 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) Rate [12 months]. Number, percentage of participants. All Participants -Chemotherapy Followed by Radiation Treatment (n=9): 33; Resection Group -Chemotherapy Followed by Radiation Treatment (n=3): 100.