Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study
HEATPAC
A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)
1 other identifier
interventional
78
1 country
1
Brief Summary
This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia (study group) versus chemoradiotherapy alone (control group) following neoadjuvant chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39 patients based on the expected overall 1 year survival advantage of +20% over the control group (p0=40%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 1, 2017
July 1, 2017
4.5 years
May 4, 2015
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (at 1 year)
Overall survival
From date of randomization until the date of death from any cause assesed at 1 year or whichever is earlier
Secondary Outcomes (3)
Progression free survival (as per Response Evaluation Criteria in Solid Tumours (RECIST), v1.1)
From date of randomization until the first docemented disease progression as evident on CECT / PET-CT / MRI as per RECIST criteria (v1.1), whichever came first assessed upto the end of study period of 60 weeks
Patterns of failure : both local and systemic (as per RECIST, v1.1)
From date of randomization until the disease progression either locally or at distant sites as evident on CECT / PET-CT / MRI as per RECIST criteria (v1.1), whichever came first assessed upto the end of study period of 60 weeks
Acute and late morbidity (as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03)
Acute or late morbidity from date of randomization until the patients death from any cause as per the CTCAE v4.03 whichever came first assessed upto the end of study period of 60 weeks
Study Arms (2)
Chemoradiotherapy (CTRT) (Control Group)
ACTIVE COMPARATORIntervention type: Drug and Radiation Intervention name: Drug (Gemcitabine) Radiation (Loco-regional radiotherapy by SIB-IMRT) Intervention description: Radiotherapy: 5 days a week (Days 1 to 5) of each week for 5.5 weeks (28 fractions), Total dose: 50.4 Gy at 1.8 Gy /fr. over 5.5 weeks Chemotherapy: Gemcitabine (400 mg / sq. m) would be administered weekly 24 hours after hyperthermia on Day 2 and after radiotherapy every week on D2
Thermochemoradiotherapy (CTRTHT)
EXPERIMENTALIntervention type: Drug, Radiation and Hyperthermia Intervention name: Drug (Gemcitabine) Radiation (Loco-regional radiotherapy by SIB-IMRT) Hyperthermia (Loco-regional hyperthermia), Intervention description: Radiotherapy: 5 days a week (Days 1 to 5) of each week for 5.5 weeks (28 fractions), Total dose: 50.4 Gy at 1.8 Gy /fr. over 5.5 weeks Chemotherapy: Gemcitabine (400 mg / sq. m) would be administered weekly 24 hours after hyperthermia on Day 2 and after radiotherapy every week on D2 Hyperthermia: Weekly Local hyperthermia before radiotherapy on D1 of every week, 41-43°C for 60 mins, once every week
Interventions
CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine
Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine
Eligibility Criteria
You may qualify if:
- Patients of locally advanced pancreatic cancer with
- Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters
- Tumor encasement (≥180°) of the superior mesentric artery or proximal hepatic artery
- Tumor abutment (\<180°) of the celiac trunk
- Tumor invasion of the aorta
- Presence of metastasis to lymph nodes beyond the field of resection
- Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology)
- Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1
- Age: 18 to 80 years
- At least one of the diameters of the primary tumor or regional lymph node or both should be greater than 4 cm, as confirmed on contrast-enhanced computed tomography (CECT).
- Patients, have primary tumor or regional lymph node or both lesser than 4 cm, as confirmed on CECT but have specific medical contraindications to stereotactic body radiation therapy or irreversible electroporation or as per patient's preference could be considered for HEATPAC.
- No evidence of any distant metastasis
- Patients with microscopic peritoneal carcinomatosis, detected on laparoscopy following 4 cycles on neo-adjuvant FOLFIRINOX would be included.
- Estimated life expectancy of at least 6 months
- Adequate kidney functionality defined as creatinine clearance \>50ml/min
- +6 more criteria
You may not qualify if:
- Histopathology other than ductal adenocarcinoma pancreas
- Prior radiotherapy to the site of treatment
- Patients with unequivocal distant metastasis including liver
- Patients with gross peritoneal carcinomatosis on laparoscopy
- No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin
- No serious medical illness which would prevent informed consent or limit survival to less than 2 years
- Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled.
- Psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements.
- Patients having metal implants, pacemakers or clustered markers.
- Metallic endobiliary stenting would be a contraindication, hence plastic stents may be used if biliary drainage is indicated.
- Patient with a history of myocardial infarction within the past 12 months
- No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma
- Pre-existing grade 2 peripheral neuropathy
- Any known contraindication or hypersensitivity to the chemotherapeutic agents
- Pregnancy, lactation period or lack of reliable contraception
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kantonsspital Aaraulead
- University of Zurichcollaborator
Study Sites (1)
Kantonsspital Aarau
Aarau, Canton of Aargau, CH 5001, Switzerland
Related Publications (1)
Datta NR, Pestalozzi B, Clavien PA, Siebenhuner A, Puric E, Khan S, Mamot C, Riesterer O, Knuchel J, Reiner CS, Bodis S; members of the HEATPAC Trial Group. "HEATPAC" - a phase II randomized study of concurrent thermochemoradiotherapy versus chemoradiotherapy alone in locally advanced pancreatic cancer. Radiat Oncol. 2017 Nov 21;12(1):183. doi: 10.1186/s13014-017-0923-8.
PMID: 29162142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niloy R Datta, MD,DNB
Kantonsspital Aarau
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant and Head, Radiation Research, Radiation Oncology
Study Record Dates
First Submitted
May 4, 2015
First Posted
May 12, 2015
Study Start
January 1, 2017
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
August 1, 2017
Record last verified: 2017-07