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* Option 1: fluorouracil(5-FU)/leucovorin/irinotecan/oxaliplatin (mFOLFIRINOX) (6 cycles)
* Option 2: gemcitabine + nab-paclitaxel (3 cycles)
* Resectable patients receive surgery 6 weeks post completion of initial chemotherapy
* Unresectable patients continue with ongoing chemotherapy (option 1 or option 2)
* Unresectable patients with locoregional progression or metastatic disease, chemotherapy treatment at the discretion of treating medical oncologist
* Adjuvant chemotherapy for resectable patients to begin within 8 weeks after surgery
* For patients who received option 1 chemotherapy: 12 weeks of mFOLFIRINOX
* For patients who received option 2 chemotherapy: 12 weeks of mFOLFIRINOX or 12 additional weeks of gemcitabine/capecitabine

* Option 1: fluorouracil(5-FU)/leucovorin/irinotecan/oxaliplatin (mFOLFIRINOX) (6 cycles)
* Option 2: gemcitabine + nab-paclitaxel (3 cycles)
* Stereotactic Radiotherapy (SBRT) to commence within 3 weeks of completing initial chemotherapy: 40 Gray (Gy) in 5 fractions over 2 weeks
* Resectable patients receive surgery 6 weeks post completion of initial chemotherapy
* Unresectable patients continue with ongoing chemotherapy (option 1 or option 2)
* Unresectable patients with locoregional progression or metastatic disease, chemotherapy treatment at the discretion of treating medical oncologist
* Adjuvant chemotherapy for resectable patients to begin within 8 weeks after surgery
* For patients who received option 1 chemotherapy: 12 weeks of mFOLFIRINOX
* For patients who received option 2 chemotherapy: 12 weeks of mFOLFIRINOX or 12 additional weeks of gemcitabine/capecitabine

40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction

Stereotactic Radiotherapy (SBRT)

* Day 1: oxaliplatin 85mg/m2 + irinotecan 150mg/m2 + leucovorin 50mg
* 5-FU 2400mg/m2 continuous IV infusion, 46 hour continuous infusion
* 14-day cycle, 6 cycles

mFOLFIRINOX

* Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
* 28-day cycle, 3 cycles

Gemcitabine + Nab-paclitaxel

* Week 1, 2 and 3, qw: 1000 mg/m2 gemcitabine
* 21 days continuous: 830 mg/m2 oral capecitabine + 7 days rest
* 28-day cycle, 3 cycles

Gemcitabine + Capecitabine

R0 resection. When the tumour is within the head of the pancreas, a standard Whipple's procedure and level 2/3 dissection with modification to obtain margin clearance will be offered. For lesions in the tail, a standard modular resection will be offered.

Pancreatoduodenectomy (Whipple procedure)

NHMRC CTC

Andrew Oar

This is a prospective, multicentre randomised, phase II clinical trial, with randomisation 2:1 by minimisation and stratification by tumour stage, planned chemotherapy and institution.

This is a prospective, multicentre randomised, phase II clinical trial to evaluate safety and activity of stereotactic body radiotherapy (SBRT) in addition to chemotherapy in patients with high-risk and borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). High risk defined as any patient with tumour \>4cm, extrapancreatic extension or node positive disease.

MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

The study will be conducted in accordance with applicable Privacy Acts and Regulations. All data generated in this study will remain confidential. All information will be stored securely at the NHMRC CTC, University of Sydney and will only be available to people directly involved with the study.

Personal data identifying trial participants will be held securely at the NHMRC CTC for the purpose of follow up if the patient is unable to/wishes to discontinue clinic based follow-up.

The list of blood biomarkers and their measurement will be updated when confirmed.

The list of tissue biomarkers and their measurement will be updated when confirmed.

Proportion of patients who are willing to use electronic device vs. paper format, Analysis of demographic data and assessing data quality between the group

To determine if the addition of SBRT to chemotherapy improves locoregional control;

Compare acute and late side effects from chemotherapy +/- SBRT

Length of stay, death within 30 days, frequency and severity of adverse events. Hospital admission during surgery will be calculated from day of surgery to date of discharge from acute care hospitalisation. The length of stay in acute hospital care will include intensive care admissions.

Compare radiologic response rates for chemotherapy +/- SBRT

Compare 12-month progression free survival

Compare pathologic response rates of chemotherapy +/- SBRT

To assess the impact of the regimens on quality of life of patients

To assess overall net clinical benefit of treatment

OS is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known alive. Participants will be censored at the date of commencement of the subsequent anti-cancer therapy.

Trans Tasman Radiation Oncology Group

Australian Government Department of Health and Ageing

Australasian Gastro-Intestinal Trials Group

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gemcitabine: 1000 mg/m2 intravenously over 30 min. on day 1 in 2-weeks cycles. Capecitabine: Peroral tablet 2000 mg/m2 daily on days 1-7 in 2-weeks cycles.

The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.

A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

Vejle Hospital

Amino Acids

Cisplatin

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons.

Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.

Carbon Ion

Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.

All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.

Gemcitabine + Cisplatin

Gemcitabine + Erlotinib

During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.

Photon

Chandan Guha, M.B.B.S., Ph.D.

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer

Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.

Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0

Radiographic changes following completion of study therapy (RECIST v. 1.1)

The length of time from study inclusion until death from any cause

The length of time from study inclusion until death from any cause or disease progression at any site

Quality of life will be assessed at various time points using the European Organisation for Research and Treatment of Cancer 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many cancer related clinical trials.

Shanghai Proton and Heavy Ion Center

Albert Einstein College of Medicine

Associate Professor

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Gemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²)

Cisplatin: 25 mg/m² as iv-infusion on days 2, 3\* and 16, 17\* of each course (Total dose: 600 mg/m²)

Regional hyperthermia: 60 minutes on days 2, 3\*, and 16, 17\* of each course

\* as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17

Gemcitabine + Cisplatin + regional hyperthermia

Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)

Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles

Rolf D. Issels, MD, PhD

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.

Hyperthermia European Adjuvant Trial

A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)

The European Society for Hyperthermic Oncology

Ludwig-Maximilians - University of Munich

Klinikum der Universitaet Muenchen, Grosshadern

MD, PhD

Recurrence

Gemcitabine alone

Richard Herrmann, MD

Werner Scheithauer, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

OBJECTIVES:

* Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
* Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer	NCT01472770	Metastatic Colo...	Gemcitabine + C...	18 Years -	Vejle Hospital
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease	NCT04089150	Pancreatic Canc...	Stereotactic Ra... mFOLFIRINOX Gemcitabine + N... Gemcitabine + C... Pancreatoduoden...	18 Years - 75 Years	Australasian Gastro-Intestinal Trials Group
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine
Hyperthermia European Adjuvant Trial	NCT01077427	Resected Pancre...	Gemcitabine + C... Gemcitabine + C...	18 Years - 75 Years	Klinikum der Universitaet Muenchen, Grosshadern
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer	NCT00030732	Pancreatic Canc...	Gemcitabine + C... Gemcitabine alo...	18 Years - 120 Years	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for gemcitabine + capecitabine