Cancer Pancreas Clinical Trial
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%).
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:
1. Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein
extending for several centimeters (precluding vein resection and reconstruction)
2. Tumor encasement (≥180°) of the superior mesentric artery or proximal hepatic artery
3. Tumor abutment (<180°) of the celiac trunk
4. Tumor invasion of the aorta
5. 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:
1. Overall survival at 1 year
2. To assess the acute and the late morbidities associated with hyperthermia and
chemoradiotherapy in concurrent chemoradiotherapy compared to concurrent
chemoradiotherapy alone.
Secondary endpoints:
1. 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.
2. To assess the patterns of failure (both local and systemic) in patients of both
treatment arms.
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