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Safety and efficacy of preoperative combination therapy of chemotherapy and hyperbaric oxygen therapy for resectable pancreatic cancer

Multicenter phase II clinical trial of preoperative chemotherapy and hyperbaric oxygen therapy for resectable pancreatic cancer - Preoperative therapy (chemotherapy and hyperbaric oxygen therapy) for resectable pancreatic cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049855
Enrollment
27
Registered
2023-01-04
Start date
2023-01-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable pancreatic cancer

Interventions

Treatment with chemotherapy and hyperbaric oxygen therapy
Chemotherapy: 2 courses S-1 40 mg/m2 twice a day for 14 days followed by a 7 days rest + Gemcitabine 1,000mg/m2 on days 1 and day 8 every 3 weeks Hyperbaric oxygen therapy : A total of 4 times

Sponsors

Division of Surgery National Hospital Organization Higashi-Ohmi General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) invasive ductal carcinoma of the pancreas 2) resectable pancreatic cancer at diagnosis 3) no distant metastasis 4) R0/1 resectable 5) Negative cytology of washed ascites by staging laparotomy or PET-CT 6) all adult who anticipate to undergo pancreatectomy 7) no prior therapy 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) pulmonary fibrosis or interstitial pneumonitis 2) frequent watery diarrhea that is resistant to treatment 3) active double cancer 4) distant metastasis 5) R2 resection 6) prior anti-cnacer therapy 7) pregnancy 8) a history of spontaneous pneumothorax, bronchial asthma, open-heart surgery, etc., and who are at risk of acute ventilation failure 9) ophthalmic treatment/after surgery (when intraocular pressure gas C3F8, SF6 is used for retinal detachment, etc.) 10) Difficult to tolerate radical surgery 11) Have an active infectious disease (fever 38.0 degrees or higher) 12) those who do not have sufficient judgment to obtain consent for this research

Design outcomes

Primary

MeasureTime frame
1 year relapse-free survival

Secondary

MeasureTime frame
Adverse effect Dose intensity Resectability rate Pathological effect Tumor marker Tumor volume Form of recurrence

Countries

Japan

Contacts

Public ContactHiroya Akabori

National Hospital Organization Higashi-Ohmi General Medical Center Division of Surgery

hakabori@belle.shiga-med.ac.jp0748-22-3030

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026