Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Ovarian Neoplasms

Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Sarcopenia

Neoplasms, Second Primary

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Breast Neoplasms

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lung Neoplasms

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Rectal Neoplasms

Kidney Neoplasms

Neoplasms by Histologic Type

Hematologic Diseases

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neoplastic Processes

Bone Marrow Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Breast Diseases

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Myeloproliferative Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Quality of Life

Ovarian Cancer

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Myeloproliferative Disorders

Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Standard

Magali BALAVOINE

Katell LE DU, MD

Julien DOMONT, MD

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.

Sarcopenia is defined for those under 60 years of age by LMSI\<43.1 cm²/m² for men and \<32.7 cm²/m² for women, and for patients over 60 years of age by \<38.6 cm²/m² for men and \<30.7 cm²/m² for women..

Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.

Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)

Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression

Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression

For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)

Calculated according to WHO classification

Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers

Weprom

Fistula

Pancreatic Fistula

Digestive System Fistula

Pancreatic Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients with cancer pancreas with soft pancreas and non-dilated pancreatic duct

Adding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures.

Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures

Abdallah M Taha, MD

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study

Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.

South Valley University

Assistant Professor

Syndrome

Pancreatic Neoplasms

Cancer Pain

Pain

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.

Superficial neuromodulation using EKG type electrodes \[Scrambler (MC5-A Calmare) Therapy\]

Scrambler Therapy Device

Thomas J Smith, MD

Pain is the predominant and most feared symptom of pancreas cancer, and is often incompletely relieved. Scrambler Therapy is a new way of treating pain by providing "non-pain" information to confuse the nervous system and reset the damaged nerve pathways. It has been useful in treating many types of pain, but has not been adequately tested in the pain associated with pancreas cancer. The goal of this study is to evaluate the effect of Scrambler Therapy on typical abdominal pain associated with pancreas cancer. The investigators hypothesize that pain scores from day 0 (pre) to day 28 (post) will be reduced by at least 33%, e.g. from 6/10 to 4/10.

Pancreas cancer causes pain in 70% of newly diagnosed patients rising to over 80% in advanced cancer patients, and is the most common serious symptom. Pancreas cancer pain is strongly correlated with worsened survival, and relief of pain is correlated with better survival. Pancreas cancer pain is neuropathic in origin and sensation, arising from direct invasion of local tissues. Pancreas cancer pain is relieved by local nerve blocks in about 75% of cases, but the relief is often incomplete, temporary, and the procedure is invasive with some risks. As the cancer grows to involve more nerves, or the nerves regrow, the pain typically comes back. For the 46,420 newly diagnosed pancreas cancer patients and the 39,500 patients who die of it each year, pain is the one constant symptom.

Scrambler Therapy is a novel treatment increasingly supported by clinical experience and multiple trials. The goal of the device is to provide "non-pain" information through the cutaneous nerves to block the effect of pain information. The device is a cutaneous electrical stimulator that creates waveforms simulating 16 different action potentials, then transmits the action potentials via C fibers. The goal is to reset the brain to perceive "non-pain" from areas previously interpreted as painful, similar to spinal cord stimulation. The multiprocessor apparatus directly stimulates the peripheral nerves by the application of surface electrodes on the skin, similar to EKG electrodes, putting the electrodes above and below the site of pain.

Preliminary data on Scrambler therapy in pancreas cancer Scrambler Therapy appears to work on pain based on results from multiple trials. In fact, the first trial was done on patients with abdominal pain from abdominal cancers. In this first trial, 11 cancer patients (3 pancreas, 4 colon, 4 gastric) suffering from drug resistant visceral pain were studied during the patients' first ten treatment sessions. The pain score before the treatment is shown next to the pain score after treatment, for each daily treatment. The electrodes were placed to surround the pain, following the dermatomes, as shown in Figure 2. The active (yellow) electrodes are always paired across the pain with the passive (black) electrode. Pain was quickly and markedly reduced and maintained until death. As then inventor wrote, "During the applications, all the patients reported a very rapid (in the order of a few seconds) disappearance of the perception of pain. All patients responded fully to the protocol and none reported undesirable side effects. Compliance was excellent." Nine of 11 stopped pain drugs within the first 5 applications. "During the reference period, nine out of eleven patients (81.8%) are seen to have stopped requesting painkillers between the second and the fifth treatment session. The remaining two patients (18.2%) considerably reduced the dosage and undertook mild therapy."

To be blunt, no one really believed these results. The magnitude of pain relief was large, with a simple machine using non-invasive therapy. To this day, the trial has not been replicated. But over the next decade, more and more evidence about Scrambler Therapy emerged from different investigators that led the investigators to believe that there was a signal worth exploring for relief in pancreas cancer. In the second trial, 226 patients with neuropathic pain including failed back surgery, brachial plexus neuropathy, and others were treated. Over 80% of patients responded with \> 50% pain relief, 10% responded with pain relief from 25% to 49%, and only 10% had no response (P\<0.0001). Based on these results the FDA approved Scrambler Therapy for cancer pain treatment February 25, 2009. The investigators have recently compiled the published reports of Scrambler Therapy for a review.

4. Study Procedures

Study Design and Treatment Plan The investigators propose a straightforward single arm trial of actual Scrambler Therapy to see if pain can be relieved. This study also serves to get preliminary information for planning future, larger, phase III studies that could compare to celiac plexus block, spinal cord stimulation, or sham treatment. The investigators anticipate completing the study in less than 12 months, with 18 completed subjects having up to 10 treatment sessions each.

Recruitment

1. Patients will be recruited through the Kimmel Cancer Center's outpatient oncology clinics, and the inpatient oncology and palliative care consult services. The palliative care service now sees over 1000 new consultations annually, with about half with cancer, and pancreas cancer pain is one of the most common reasons for consultation.

Treatment Days

Day 1/Treatment Initiation:

1. Treatment should be initiated by turning on the stimulus for the first electrode pair. The intensity of the stimulus is increased until the patient can first feel some sensation associated with one or both of the electrodes. Script: "Tell me when something is felt."
2. Then, over a few seconds, the intensity is increased to what is maximally tolerated. "Tell me when tolerance has been reached." In practice, this has been universally understood.
3. Once the intensity is at its maximum setting, the research therapist will evaluate the level of pain. If the pain level is not decreased, the machine will be reset to zero, the electrodes will be repositioned and the machine will be restarted in the manner described above. If the pain is not resolved with one set of electrodes, a second set will be applied in a similar fashion. Once satisfactory electrode placement and stimulus intensity is determined, therapy is maintained for a total of 30 minutes.
4. If a patient develops pain or a burning sensation with any of the electrodes, then the treatment should be interrupted and the electrode should be evaluated. Considerations include subjective patient intolerance, stimulation of a cutaneous nerve branch, or exacerbation of hyperesthesia or allodynia associated with the neuropathic process. These problems can be addressed by moving one or both of the electrodes farther away from the area of pain. For the electrodes that were moved, the intensity should again be increased and maintained at maximum for 30 minutes as described above.

Days 2-10:

1. Treatment will be administered using the same principles (each day evaluated independently and not necessarily reproducing the electrode arrangements and stimulation parameters of the previous day) for 30 minutes on consecutive days (Monday-Friday for 2 weeks).
2. Up to two or three days may be skipped to allow for weekends and/or holidays, if needed. If the participant presents without any pain, then the treatment will be "held" for that day and this information will be recorded.
3. Treatment does not proceed if the patient does not have pain.

Dose and Application

1. Electrodes are applied on the skin surrounding the pain-affected area.
2. The electrodes are never applied directly on the pain area, unless there is no pain free area. In that case, the electrode will be applied to the most pain

Statistical Considerations Overall This is a single-arm, pilot study to evaluate the effect of Scrambler Therapy for patients with pancreas cancer who have an average daily pain rating of ≥4 out of 10 based on the Modified Brief Pain Index, question #3.

Sample Size and Accrual The investigators are anticipating that the starting pain score on average will be ≥4 based on Virginia Commonwealth (VCU), Hopkins, Italian, and Mayo Clinic data. The investigators are conservatively anticipating that a relative reduction in average pain score by Day 28 will be 33%, a level which is considered minimal clinically important, based on the VCU, Italian, Mayo Clinic, and Walter Reed data. It is anticipated that approximately 90% of the patients will agree to be re-evaluated at Day 28 and have paired ratings available for evaluation. Thus, the study will enroll 20 patients expecting 18 to be evaluable for the primary endpoint. Based on prior studies, the investigators assume that the average pain value at baseline is at least 4 on a 0-10 scale with a standard deviation (SD) of the original pain value expected to fall in the range of 1-1.5 in this patient population.

As such, a conservative estimate of the standard deviation of the change across patients from Day 0 to Day 28 would be approximately up to 2. Using a one-sample paired t test with a sample size of 18 patients, this design will provide at least 80% power to detect a minimum of 33% reduction in average pain score at Day 28 compared to Day 0 with a two-sided type I error of 5%. The table below shows statistical power under different scenarios of a range of baseline pain scores and intra-patient correlation for a 33% relative reduction at Day 28. In the situation when variation of the starting pain score is larger than expected (e.g., SD=2.0), the sample size remains sufficient for this endpoint if the patients have moderate to severe pain to start with (i.e., 5 or above).

Analysis of Primary Endpoint

1. Baseline and change at Day 28 in average daily pain score will be treated as continuous variables and summarized with descriptive statistics. Each will be explored to determine if transformations (e.g. log or square-root) are necessary to achieve normality.
2. Exploratory plots will be created and means will be estimated along with 95% confidence intervals.
3. The investigators will use the paired t-test and Wilcoxon sign rank test as appropriate to determine whether or not the data shows evidence of change from baseline.
4. The primary analysis will include all patients who have received at least one session of treatment; the investigators' experience is that \>90% will complete treatment.
5. A sensitivity analysis may be performed with patients who have completed 10 sessions of treatment, but the investigators anticipate that this highly motivated group will have \>90% completion rates.

Analysis of Secondary Endpoints

1. All of the secondary endpoints will be summarized by item and by type of questionnaire, respectively, using descriptive statistics. A summary score of Brief Pain Inventory (BPI) will also be calculated by adding the total number of points across items.
2. The normality of distributions will be assessed and transformations be made as appropriate. Mean changes will be estimated with 95% confidence intervals. Changes from baseline will be evaluated using paired t tests or Wilcoxon signed rank tests.
3. A repeated measure of analysis of variance (ANOVA) will be used to test if there are any changes over time on pain scores.
4. Adjustment for multiple comparisons will not be made due to the pilot nature of study seeking to generate hypotheses to be tested in future larger randomized trials.

A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer

Change in average pain will be evaluated using the Brief Pain Inventory Question 3. This is scored from 0 to 10 with 0 being no pain and 10 being worst pain.

The change in pain will be assessed by the standard Brief Pain Inventory which has 35 items with an overall scoring of 0 to 10. A score of 0 means no pain and a score of 10 means worst pain.

The amount of opioids in milligrams used between day 0 and day 28 will be converted to morphine equivalents to assess any change in the amount of opioid used.

Ho-Chiang Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Postoperative Complications

The anti-mesenteric border of the jejunal loop proximal to the hepatico-jejunostomy is brought against the pancreatic stump. With the pancreatic stump retracted by the stay sutures, the transected end of pancreatic duct is first identified and secured by means of a blunt tipped probe. Each trans-pancreatic, suture was performed using a single Polydioxanone (PDS) 3 -0 blunt needle. We usually take 4 sutures, 2 on each side of the duct. The process is repeated in the same manner with the remaining sutures which are tightened at the end to approximate the jejunum loop to the stump. A small stab incision is then made at the anti-mesenteric border of the jejunum and a duct to mucosa anastomosis is constructed using an interrupted 5-0 Prolene. The process is completed by placing each of the retained needles through the seromuscular layer of the anterior jejunal wall and each knot is tied over the jejunal wall which is then warped over the cut end of the stump

Blumgart Anastomosis

It is a two layer, interrupted, end to side pancreatico-jejunostomy. First an interrupted sutures between the posterior capsule and the seromuscular layer of the jejunum was constructed using PDS 3-0 , then a duct to mucosa interrupted sutures were taken using PDS 5-0 and finally interrupted sutures between the anterior capsule and the jejunum . The main difference here is that the sutures are taken in a conventional way which is tangential to the pancreatic capsule and parenchyma

Cattell Warren Anastomosis

Ehab A Abdulmaksoud, Master

Haitham A Othman, MD

Ehab A Abdulmaksoud, master

The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.

Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design

The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding

* Surgical technique
* Peri-operative outcome including

  1. Length of hospital stay
  2. Post-operative pancreatic fistula
  3. ICU admission and stay
  4. Operative time
  5. Other morbidity and mortality

Data collection:

All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.

Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

Comparison Between Blumgart Anastomosis and Cattell Warren Anastomosis in Reduction of Post-Operative Complications After Pancreaticoduodenectomy Procedure

We used the International Study Group of Pancreatic Fistula (ISGPF) definition which is any measurable pancreatic fluid output after postoperative day 3 (containing more than three times the normal serum amylase level; more than 300 IU/L) with clinical signs of an infection and/or necessitating a change in clinical management.

Any biliary output via percutaneous drains after the first postoperative day, or detected at a re-laparotomy

including early and late bleeding (1-3 weeks post-operative) According to ISGPF it is defined as any bleeding from the surgical site with a drop in hemoglobin concentration greater than 3 g/dL with peripheral circulatory impairment requiring medical, surgical, or radiological intervention.

Bleeding that occurs during or in the first day after the operation

Cairo University

Assistant Lecturer of Surgical Oncology

Wounds and Injuries

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antineoplastic Agents

Gemcitabine

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

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

CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine

Chemoradiotherapy (CTRT)

Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine

Thermochemoradiotherapy (CTRTHT)

Niloy R Datta, MD,DNB

Stephan Bodis, MD

Niloy R Datta, MD, DNB

Emsad Puric, MD

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.

Hyperthermia with chemoradiotherapy vs. Chemoradiotherapy alone

Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study

A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy	NCT05154474	Metastatic Canc... Cancer, Breast Cancer Colon Cancer, Rectum Cancer, Lung Cancer Ovaries Cancer Prostate Cancer, Kidney Cancer Pancreas Myeloma Myelodysplasia Leukemia, Myelo... Leukemia,Myeloi... Leukemia, Lymph... Leukemia, Lymph...	Standard	18 Years -	Weprom
Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure	NCT05682768	Pancreatic Fist...	Duct to Mucosa ...	19 Years - 80 Years	South Valley University
A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer	NCT03707444	Cancer Pancreas Pain Syndrome Cancer Related ...	Scrambler Thera...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy	NCT05163977	Cancer of Pancr...	Blumgart Anasto... Cattell Warren ...	-	Cairo University
A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer	NCT03707444	Cancer Pancreas Pain Syndrome Cancer Related ...	Scrambler Thera...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study	NCT02439593	Cancer Pancreas	Chemoradiothera... Thermochemoradi...	18 Years - 80 Years	Kantonsspital Aarau

Spots Global Cancer Trial Database for cancer pancreas