Clinical trial · Interventional
Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)
NCT01683422CI-TRIAL-00053190terminatedN/AResults 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): Updated chemotherapy regimens currently evaluated in clinical trials due to lack of progress in treating this condition; analysis continues in the realm of patterns of failure and increasing quality of life
Summary
Brief summary (as posted)
The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton, Gemcitabine, Erlotinib, Capecitabine | Radiation | — | UNRESOLVED |
| Proton Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Radiation
- description
- Pre-Proton-chemotherapy (PCT) Patients will receive a combination of the agents (Gemcitabine plus Erlotinib) for 8 weeks prior to PCT Gemcitabine 1000 mg/m2 IV, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 PCT to be started in 4 to 8 weeks after completion of Pre-PCT Proton therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day for 5 ½ weeks. Chemotherapy: Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed Post-PCT to be started in 4 to 6 weeks after completion of PCT Oxaliplatin 130 mg/m2, day 1 Capecitabine 1000 mg/m2 po bid on days 2 to 15 for 14 days The CapOx regimen (Capecitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles
- interventionNames
- Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine
- Radiation: Proton Radiation
Primary outcomes (1)
- measure
- One-year Survival Rate
- timeFrame
- One year after treatment completed.
- description
- Subjects will be followed after treatment completed to determine length of survival rate. The primary study objective was 1-year overall survival (OS, failure: death due to any cause). The Kaplan-Meier method was used to estimate the one-year OS. Secondary Objectives were the frequency of serious adverse events, disease control rate and progression-free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas * The American Joint Committee on Cancer (AJCC) stage I-III with unresectable or borderline unresectable disease as defined by NCCN guidelines * Radiological resectability is defined by the following criteria on abdominal imaging: 1. No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery. 2. No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence 3. No evidence of visceral or peritoneal metastases * Borderline and Unresectable cases would be defined as those that do not meet the criteria in section and also show no evidence of distant metastatic or intraperitoneal disease. * Eastern Cooperative Oncology Group performance status of ≤ 2 * Age \> 18 years * Adequate hematologic reserve, hepatic reserve and renal function * White Blood Cell (WBC) \> 2,000 cells/mm3 * Absolute Neutrophil Count (ANC) \> 1,500 cells/mm3 * Platelets \> 100,000 cells/mm3 * Serum bilirubin ≤ 2.5 mg/dL * Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min * Alanine aminotransferase (ALT) \< 3 times ULN * Aspartate transaminase (AST) \< 3 times ULN * Albumin \> 3.2 g/dl * Patient must sign study-specific informed consent Exclusion Criteria: * AJCC stage IV with metastatic disease * Eastern Cooperative Oncology Group performance status of \> 2 * Age \< 18 years * WBC \< 2,000 cells/mm3 * ANC \< 1,500 cells/mm3 * Platelets \> 100,000 cells/mm3 * Serum bilirubin \> 2.5 mg/dL * Serum creatinine \> 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min * ALT \> 3 times ULN * AST \> 3 times ULN * Albumin \< 3.2 g/dl
References
Publications (1)
- DERIVEDSanghvi SM, Coffman AR, Hsueh CT, Kang J, Park A, Solomon NL, Garberoglio CA, Reeves ME, Slater JD, Yang GY. A phase II trial of gemcitabine and erlotinib followed by ChemoProton therapy plus capecitabine and oxaliplatin for locally advanced pancreatic cancer. J Gastrointest Oncol. 2022 Aug;13(4):1989-1996. doi: 10.21037/jgo-22-327. PMID 36092320