Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study (HEATPAC)
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|ClinicalTrials.gov Identifier: NCT02439593|
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pancreas||Other: Chemoradiotherapy (CTRT) Other: Thermochemoradiotherapy (CTRTHT)||Phase 2|
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.
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Hyperthermia with chemoradiotherapy vs. Chemoradiotherapy alone|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Chemoradiotherapy (CTRT) (Control Group)
Drug and Radiation
Drug (Gemcitabine) Radiation (Loco-regional radiotherapy by SIB-IMRT)
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
Other: Chemoradiotherapy (CTRT)
CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine
Experimental: Thermochemoradiotherapy (CTRTHT)
Drug, Radiation and Hyperthermia
Drug (Gemcitabine) Radiation (Loco-regional radiotherapy by SIB-IMRT) Hyperthermia (Loco-regional hyperthermia),
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
Other: Thermochemoradiotherapy (CTRTHT)
Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine
- 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
- 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 ]Progression free survival
- 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 ]Patterns of failure : both local and systemic
- 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 ]Acute and late morbidity that are ascribed to treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439593
|Contact: Niloy R Datta, MD,DNBemail@example.com|
|Contact: Stephan Bodis, MDfirstname.lastname@example.org|
|Principal Investigator:||Niloy R Datta, MD,DNB||Kantonsspital Aarau|