Unique ID issued by UMIN | UMIN000028626 |
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Receipt number | R000032763 |
Scientific Title | A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic |
Date of disclosure of the study information | 2017/08/10 |
Last modified on | 2019/03/18 22:39:27 |
A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
Japan | North America |
Locally Advanced, Unresectable Pancreatic Cancer
Radiology |
Malignancy
NO
To compare the efficacy of carbon ion-based chemoradiotherapy with x-ray-based chemoradiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment.
Efficacy
2 years overall survival, defined from the date of randomization to death
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine | Device,equipment |
Radiotherapy
Chemotherapy
18 | years-old | <= |
Not applicable |
Male and Female
1.All patients must be willing and capable to provide informed consent to participate in the protocol.
2.Histological and/or cytological diagnosis of pancreas adenocarcinoma within 60 days of registration
3.Unresectable by radiographic or exploration within 30 days of registration
4.Age =or > 18 years.
5.Distance from the pancreas tumor edge to the bowel and stomach > 3 mm (in both the prone and supine positions)
6.Tumor does not exceed 15 cm in greatest dimension
7.No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen a8.Zubrod performance status of 0-1, within 30 days prior to registration (Appendix B)
9.MP and CBC with differential obtained within 14 days prior to registration (may be taken after stent placement), with adequate hematologic variables as defined by:
Absolute neutrophil count > 1500 cells/mm3
Creatinine <1.5 mg/dL
Hemoglobin >8.0 g/dL
AST and ALT < 2.5 X ULN
Bilirubin < 1.5 times the ULN (after stent placement, if necessary)
10.Patients must complete all required pretreatment evaluations (section 5.0)
11.Able to travel to a foreign country within approximately 2 weeks of randomization (for patients enrolled at UTSW)
12. Women of childbearing potential and male participants must agree to use an effective method of contraception.
1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
1.Subjects receiving other investigational agents.
2.History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study.
3.Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
4.Prior treatment for pancreatic cancer preceding registration
5.Prior radiation to the upper abdomen
6.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
7.Body weight >100 kg
8.Active inflammatory bowel disease or active gastric/duodenal ulcer
9.Metal implants in the upper abdomen
10.Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy.
11.History of HIV or hepatitis B or C
103
1st name | |
Middle name | |
Last name | David J. Sher |
University of Texas Southwestern Medical Center
Department of Radiation Oncology
5801 Forest Park Rd, Dallas, TX 75390
14-645-7607
David.Sher@UTSouthwestern.edu
1st name | |
Middle name | |
Last name | Shigeru Yamada, MD, PhD |
National Institute for Radiological Sciences (NIRS) (Japan)
Department of Charged Particle Therapy
4-9-1Anagawa, Inageku, Chiba
043-206-3306
yamada.shigeru@qst.go.jp
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Outside Japan
YES
17-015
National INstitute for Quantum and Radiological Science and Technology
2017 | Year | 08 | Month | 10 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 03 | Day |
2019 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 27 | Day |
2023 | Year | 02 | Month | 27 | Day |
This trial has moved from UMIN to JRCT.
2017 | Year | 08 | Month | 10 | Day |
2019 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032763
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