Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02439593
• Date of registration: 04/05/2015
• Prospective Registration: Yes
• Primary sponsor: Kantonsspital Aarau
• Public title: Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study HEATPAC
• Scientific title: A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)
• Date of first enrolment: January 1, 2017
• Target sample size: 78
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02439593
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Niloy R Datta, MD, DNB

• Name: Niloy R Datta, MD,DNB

• Name: Niloy R Datta, MD,DNB
• Affiliation: Kantonsspital Aarau

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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

2. Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology)

3. Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1

4. Age: 18 to 80 years

5. 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).

6. 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.

7. No evidence of any distant metastasis

8. Patients with microscopic peritoneal carcinomatosis, detected on laparoscopy following
4 cycles on neo-adjuvant FOLFIRINOX would be included.

9. Estimated life expectancy of at least 6 months

10. Adequate kidney functionality defined as creatinine clearance >50ml/min

11. Adequate liver functionality defined as total bilirubin = 2x of the upper limit of
normal

12. Adequate bone marrow reserves: White blood cell count = 2.5 x 10^9/L, Platelet count =
100 x 10^9/L, Hemoglobin = 8.0g/L

13. Women of child-bearing age must secure sufficient contraception control during the
clinical trial and six months after the clinical trial is completed

14. For females of child bearing potential, negative pregnancy test within 2 week prior to
randomization.

15. Female patients should not be lactating

16. Absence of psychological, familial, sociological or geographical condition that could
potentially hamper compliance with the study protocol and follow-up schedule

Exclusion Criteria:

1. Histopathology other than ductal adenocarcinoma pancreas

2. Prior radiotherapy to the site of treatment

3. Patients with unequivocal distant metastasis including liver

4. Patients with gross peritoneal carcinomatosis on laparoscopy

5. No prior or concurrent malignancies other than surgically treated squamous cell or
basal cell carcinoma of the skin

6. No serious medical illness which would prevent informed consent or limit survival to
less than 2 years

7. Active uncontrolled bacterial, viral or fungal infections until these conditions are
corrected or controlled.

8. Psychiatric or addictive disorders or other conditions that would preclude the patient
from meeting the study requirements.

9. Patients having metal implants, pacemakers or clustered markers.

10. Metallic endobiliary stenting would be a contraindication, hence plastic stents may be
used if biliary drainage is indicated.

11. Patient with a history of myocardial infarction within the past 12 months

12. No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma

13. Pre-existing grade 2 peripheral neuropathy

14. Any known contraindication or hypersensitivity to the chemotherapeutic agents

15. Pregnancy, lactation period or lack of reliable contraception

16. Any other disease or therapy, which, present a risk to the patient or which are not
compatible with the aims of the clinical trial

17. Patients would express their inability to travel on their own to Kantonsspital Aarau,
(KSA) for hyperthermia treatment

18. Indications that the person concerned will be noncompliant to the clinical trial plan
because of unwillingness to cooperate or difficulties in keeping the check-up
appointments



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cancer Pancreas

Intervention(s)

Other: Thermochemoradiotherapy (CTRTHT)

Other: Chemoradiotherapy (CTRT)

Primary Outcome(s)

Overall survival (at 1 year) [Time Frame: From date of randomization until the date of death from any cause assesed at 1 year or whichever is earlier]

Secondary Outcome(s)

Patterns of failure : both local and systemic (as per RECIST, v1.1) [Time Frame: 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]

Progression free survival (as per Response Evaluation Criteria in Solid Tumours (RECIST), v1.1) [Time Frame: 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]

Acute and late morbidity (as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03) [Time Frame: 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]

Secondary ID(s)

HEATPAC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Zurich