STEM PACE - Stem cell Transplantation for Eradication of Minimal PAncreatic cancer persisting after surgical Excision
| ISRCTN | ISRCTN47877138 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47877138 |
| Clinical Trials Information System (CTIS) | 2012-003528-19 |
| Protocol serial number | 130311StemPace |
| Sponsor | Ruprecht-Karls-University Heidelberg (Germany) |
| Funder | Heidelberg Surgery Foundation, University of Heidelberg (Germany) |
- Submission date
- 25/03/2013
- Registration date
- 09/05/2013
- Last edited
- 28/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Pancreatic cancer is the third most common cancer related cause of death. Even in the 15% of patients who are eligible for surgical resection, less than 10% of patients surviving after 5 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an established treatment capable of curing a variety of hematopoietic malignancies, taking advantage of the graft-versus-tumor effect (GVT). It works best when the underlying neoplasm has been turned into a stage of minimal disease by chemotherapy. There have been attempts of applying allo-HSCT to advanced solid tumors including pancreatic cancer with limited success but studies of allo-HSCT in solid tumors in minimal disease situations have never been performed. The aim of this study is to provide evidence for the clinical value of allo-HSCT in pancreatic cancer put into a minimal disease status by effective surgical resection and standard adjuvant chemotherapy. We want to find out if allo-HSCT can change the unfavourable natural course of this disease and whether allo-HSCT is able to provide long-term disease control to an extent otherwise not possible in pancreatic cancer and improve survival of affected patients.
Who can participate?
Patients with histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months at the University Hospital Heidelberg, who are matching the inclusion criteria.
What does the study involve?
Patients will undergo conditioning for allo-HSCT (fludarabine 30mg/mE2/d d -6 through d -2, cyclophosphamide 60mg/kg/d d-3 and d -2) followed by transplantation of allogeneic unmanipulated peripheral blood stem cells on d 0. Standard GVHD prophylaxis with CSA (target level 150-200; start d -1, taper d +60 onwards in the absence of GVHD) and MMF (2x1g; start d 0, stop d +30 in the absence of acute GVHD) will be instituted.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Clinic of General Surgery, Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
From May 2012 to June 2016
Who is funding the study?
Heidelberg Surgery Foundation, University of Heidelberg (Germany)
Who is the main contact?
Klinisches Studienzentrum der Chirurgie (KSC)
ksc@med.uni-heidelberg.de
Contact information
Scientific
University of Heidelberg
Clinic of General Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-arm single-centre open phase-I/II trial using historical controls |
| Secondary study design | Non randomised controlled trial |
| Scientific title | A phase-I/II study on the value of adjuvant allogeneic hematopoietic stem cell transplantation in pancreatic cancer after surgical resection |
| Study acronym | STEM PACE |
| Study objectives | The principal question addressed is whether allo-HSCT can change the unfavourable natural course of pancreatic cancer. |
| Ethics approval(s) | Approved by the independent Medical Ethics Committee of the University of Heidelberg (EC) and the Paul-Ehrlich-Institute (PEI), as competent authority, 22/03/2013 |
| Health condition(s) or problem(s) studied | Pancreatic cancer resected in curative intention (Adjuvant setting) |
| Intervention | Eligible patients will be screened immediately after successful surgical resection, have a donor search initiated, and subjected to standard adjuvant chemotherapy. Only those patients who underwent adjuvant chemotherapy without disease progression and who have a matched related stem cell donor available will be registered for the trial. Patients without a matched related donor will not be registered for the trial but may be used a historical control outside of the protocol. Patients will undergo conditioning for allo-HSCT (fludarabine 30mg/mE2/d d -6 through d -2, cyclophosphamide 60mg/kg/d d-3 and d -2) followed by transplantation of allogeneic unmanipulated peripheral blood stem cells on d 0. Standard graft-versus-host disease (GVHD) prophylaxis with cyclosporine (CSA) (target level 150-200; start d -1, taper d +60 onwards in the absence of GVHD) and mycophenolate mofetil (MMF) (2x1g; start d 0, stop d +30 in the absence of acute GVHD) will be instituted. |
| Intervention type | Drug |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | allogeneic hematopoietic stem cell |
| Primary outcome measure(s) |
2-year progression-free survival (PFS) from registration. |
| Key secondary outcome measure(s) |
1. 2-year PFS and overall survival (OS) after surgical resection |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 12 |
| Key inclusion criteria | 1. Histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months at the University Hospital Heidelberg 2. Hartwig score 1 or 2 (Millenium paper) 3. Measurable tumor serum marker (i.e. CA 19-9) prior to resection 4. Age at registration 18 to 65 years, either sex 5. Karnofsky index > /=70 6. Hematopoietic cell transplantation comorbidity index (HCT-CI) score 0-1 (pancreatic carcinoma does not count against the score) 7. HLA-identical (10/10 intermediate-resolution) related donor 8. Written informed consent, signed and dated |
| Key exclusion criteria | 1. Hartwig score ≤ 0 (Millenium paper) 2. HIV, HBV, HCV seropositivity 3. Organ dysfunction 4. Symptomatic coronary artery disease or ejection fraction <35% 5. DLCO ≤60%, FEV1 <65% of predicted FEV1 despite appropriate treatment or receiving supplementary continuous oxygen 6. Liver function abnormalities: Patients with will be excluded if total serum bilirubin >1.5 X ULN, or AST/ALT >2.5XULN 7. Chronic renal dysfunction defined by a creatinine clearance <50 ml/min. 8. Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment 9. Females who are pregnant or breastfeeding 10. Active other malignancies and/or a history of another malignancy treated by chemotherapy or radiotherapy within the last five years prior to inclusion 11. Patients with systemic, uncontrolled infections 12. Current alcohol or drug abuse 13. Inability to understand the scope of the study and intent of treatment. Dementia or altered mental status that would prohibit understanding informed consent 14. Participation in another interventional clinical trial according to the Arzneimittelgesetz within 30 days prior to inclusion |
| Date of first enrolment | 01/05/2013 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/03/2014 | Yes | No | |
| Basic results | 28/05/2020 | No | No |
Editorial Notes
28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
