Clinical trial · Interventional
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)
NCT01754623CI-TRIAL-00018814terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of pre-treatment tissue to make the study plan feasible.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Restaging review after radiation | Other | — | UNRESOLVED |
| Stereotactic body radiation therapy (SBRT) | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy Followed by Radiation Treatment
- description
- Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
- interventionNames
- Drug: Capecitabine
- Drug: Gemcitabine
- Drug: Docetaxel
- Radiation: Stereotactic body radiation therapy (SBRT)
- Other: Restaging review after radiation
- Procedure: Surgery
- Drug: 5-Fluorouracil
Primary outcomes (1)
- measure
- Margin-negative (R0) Resection Rate
- timeFrame
- Up to 3 years
- description
- R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as: * circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over \</= 180° * circumferential tumor abutment with the superior mesenteric artery (SMA) over \</= 180° * Short segment encasement (360°) of the PV or SMV that is amenable to partial vein resection and reconstruction * encasement of the gastroduodenal artery up to the origin of the hepatic artery * Patients must have measurable disease * No previous chemotherapy or radiation to the pancreas * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 (Karnofsky \>/= 60%) * Patients must have normal organ and marrow function as defined below: * leukocytes \>/= 3,000/μL * absolute neutrophil count \>/= 1,000/ μL * platelets \>/= 100,000/ μL * creatinine within normal institutional limits (ULN) * total bilirubin will allow for 2x the upper limit of the institution. Patients may have biliary stents or drains to lower total bilirubin to this range. * Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with metastatic disease are ineligible. * Patients who have had prior chemotherapy for pancreatic adenocarcinoma * Patients who have received prior radiation to an abdominal site are not eligible. * Patients with peripheral neuropathy \>/= grade 2 * Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine * Patients may not be receiving any other investigational agents. * ECOG Performance Status 3-4 * Pregnant or breast-feeding women are excluded from this study because gemcitabine,capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects. * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.
References
Publications (1)
- DERIVEDStrom T, Hoffe SE, Fulp W, Frakes J, Coppola D, Springett GM, Malafa MP, Harris CL, Eschrich SA, Torres-Roca JF, Shridhar R. Radiosensitivity index predicts for survival with adjuvant radiation in resectable pancreatic cancer. Radiother Oncol. 2015 Oct;117(1):159-64. doi: 10.1016/j.radonc.2015.07.018. Epub 2015 Jul 30. PMID 26235848