Cancer PancreasPhase 2HEATPACNCT02439593
Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study
A Phase 2 study testing Chemoradiotherapy (CTRT) and Thermochemoradiotherapy (CTRTHT) in people with Cancer Pancreas, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Pancreas
- What is being tested?
- Chemoradiotherapy (CTRT) and Thermochemoradiotherapy (CTRTHT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Adequate liver functionality defined as total bilirubin ≤ 2x of the upper limit of normal
- 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
- Women of child-bearing age must secure sufficient contraception control during the clinical trial and six months after the clinical trial is completed
- For females of child bearing potential, negative pregnancy test within 2 week prior to randomization.
- Female patients should not be lactating
- Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule
Who cannot join
- 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
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- 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
- Any other disease or therapy, which, present a risk to the patient or which are not compatible with the aims of the clinical trial
- Patients would express their inability to travel on their own to Kantonsspital Aarau, (KSA) for hyperthermia treatment
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, CH 5001
Niloy R Datta, MD, DNB, 0041 62 8389559, niloyranjan.datta@ksa.ch
Emsad Puric, MD, 0041 92 85385, Emsad.Puric@ksa.ch
About this study
Official title: A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)
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%).
Read the detailed description
This phase II randomized trial is a part of the comprehensive protocol designed for the locally advanced pancreatic cancers (LAPC). All patients of LAPC, fulfilling the following criteria of "Unresectable LAPC" would be considered to be eligible for enrolment in the study.
These include:
- Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters (precluding vein resection and reconstruction)
- 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 All patients would be reviewed at the Pancreas Cancer Tumor Board, University Hospital Zurich and those fulfilling the above condition/s would be considered for the study protocol of LAPC. Following a detailed work up, all eligible patients with primary tumours more than 4 cm would be considered for HEATPAC study.
Patients would be randomized by random digit using a double blinded strategy into either (a) Control group : Treated with concurrent chemoradiotherapy or (b) Study group: Treated with local hyperthermia along with concurrent chemoradiotherapy.
Treatment in both groups would be initiated with 4 cycles of neo-adjuvant chemotherapy (FOLFIRINOX). At completion of 4 cycles of neo-adjuvant FOLFIRINIOX, patients would be evaluated by PET-CT, 3-4 week following the last cycle of FOLFIRINIOX. Patients in control group would be taken up for concurrent gemcitabine (400 mg / sq.m weekly) along with loco-regional radiotherapy by SIB-IMRT to a dose of 50.4 Gy in 28 fractions. Patients in the study group would be receiving loco-regional hyperthermia to a temperature of 40-41°C, weekly for 1 hour before gemcitabine and before radiotherapy. The gemcitabine and in loco-regional radiotherapy in study group would be similar to that of the control group.
Following the completion of this treatment, patients of both groups would be considered for 8 cycles of adjuvant FOLFIRINOX and followed up with both clinical, heamatological and imaging studies as detailed in the study protocol.
Primary endpoint:
- Overall survival at 1 year
- To assess the acute and the late morbidities associated with hyperthermia and chemoradiotherapy in concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone.
Secondary endpoints:
- To compare the disease free survival in patients of locally advanced pancreatic cancers following neoadjuvant chemotherapy with FOLOFIRINOX treated with hyperthermia and chemoradiotherapy versus chemoradiotherapy alone.
- To assess the patterns of failure (both local and systemic) in patients of both treatment arms.
- Conditions
- Cancer Pancreas
- Being tested
- Chemoradiotherapy (CTRT), Thermochemoradiotherapy (CTRTHT)
- Keywords
- Pancreas, chemoradiotherapy, hyperthermia
- Medical subject headings
- Pancreatic Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoradiotherapy (CTRT)Other
CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine
Thermochemoradiotherapy (CTRTHT)Other
Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy (CTRT) (Control Group) | Active comparator | Intervention 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 Receives: Other: Chemoradiotherapy (CTRT) |
| Thermochemoradiotherapy (CTRTHT) | Experimental | Intervention 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 Receives: Other: Thermochemoradiotherapy (CTRTHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (at 1 year)
Overall survival
Measured: 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)
Progression free survival
Measured: 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)
Patterns of failure : both local and systemic
Measured: 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 and late morbidity that are ascribed to treatment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hyperthermia with chemoradiotherapy vs. Chemoradiotherapy alone
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Prof. Dr. med. Niloy Ranjan Datta, Kantonsspital Aarau
- Investigators
- Niloy R Datta, MD,DNB, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439593
- Sponsor's protocol ID
- HEATPAC
- Acronym
- HEATPAC
- Status last verified
- Jul 2017
- First submitted
- 4 May 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29162142
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)
- ClinicalTrials.gov ID
- NCT02439593
- Acronym / sponsor ID
- HEATPAC / HEATPAC
- Conditions
- Cancer Pancreas
- Keywords
- Pancreas, chemoradiotherapy, hyperthermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Detailed description
This phase II randomized trial is a part of the comprehensive protocol designed for the locally advanced pancreatic cancers (LAPC). All patients of LAPC, fulfilling the following criteria of "Unresectable LAPC" would be considered to be eligible for enrolment in the study.
These include:
- Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters (precluding vein resection and reconstruction)
- 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 All patients would be reviewed at the Pancreas Cancer Tumor Board, University Hospital Zurich and those fulfilling the above condition/s would be considered for the study protocol of LAPC. Following a detailed work up, all eligible patients with primary tumours more than 4 cm would be considered for HEATPAC study.
Patients would be randomized by random digit using a double blinded strategy into either (a) Control group : Treated with concurrent chemoradiotherapy or (b) Study group: Treated with local hyperthermia along with concurrent chemoradiotherapy.
Treatment in both groups would be initiated with 4 cycles of neo-adjuvant chemotherapy (FOLFIRINOX). At completion of 4 cycles of neo-adjuvant FOLFIRINIOX, patients would be evaluated by PET-CT, 3-4 week following the last cycle of FOLFIRINIOX. Patients in control group would be taken up for concurrent gemcitabine (400 mg / sq.m weekly) along with loco-regional radiotherapy by SIB-IMRT to a dose of 50.4 Gy in 28 fractions. Patients in the study group would be receiving loco-regional hyperthermia to a temperature of 40-41°C, weekly for 1 hour before gemcitabine and before radiotherapy. The gemcitabine and in loco-regional radiotherapy in study group would be similar to that of the control group.
Following the completion of this treatment, patients of both groups would be considered for 8 cycles of adjuvant FOLFIRINOX and followed up with both clinical, heamatological and imaging studies as detailed in the study protocol.
Primary endpoint:
- Overall survival at 1 year
- To assess the acute and the late morbidities associated with hyperthermia and chemoradiotherapy in concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone.
Secondary endpoints:
- To compare the disease free survival in patients of locally advanced pancreatic cancers following neoadjuvant chemotherapy with FOLOFIRINOX treated with hyperthermia and chemoradiotherapy versus chemoradiotherapy alone.
- To assess the patterns of failure (both local and systemic) in patients of both treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hyperthermia with chemoradiotherapy vs. Chemoradiotherapy alone
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy (CTRT) (Control Group) | Active comparator | Other: Chemoradiotherapy (CTRT)Intervention 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) | Experimental | Other: Thermochemoradiotherapy (CTRTHT)Intervention 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients of locally advanced pancreatic cancer with
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemoradiotherapy (CTRT)CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine | Other | Chemoradiotherapy (CTRT) (Control Group) |
| Thermochemoradiotherapy (CTRTHT)Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine | Other | Thermochemoradiotherapy (CTRTHT) |
Primary outcome
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
Overall survival
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 29162142Datta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niloy R Datta, MD,DNB principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiotherapy (CTRT) and Thermochemoradiotherapy (CTRTHT) in people with Cancer Pancreas, run by Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niloy R Datta, MD,DNB (+41628422088, niloyranjan.datta@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.