Tianjin medical university hospital and institute
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Location contact
Jihui Hao
PRINCIPAL_INVESTIGATOR
Maobin Meng
CONTACT
Maobin Meng
SUB_INVESTIGATOR
NCT Number: NCT07632118
Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients. Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients. Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications). Radiotherapy is one of the most commonly used local treatment methods. It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control. After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear. However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer. Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce. Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Jihui Hao
PRINCIPAL_INVESTIGATOR
Maobin Meng
CONTACT
Maobin Meng
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy. Radiotherapy target and dose: Tumor bed, anastomosis, adjacent lymphatic drainage area :50 Gy; R1 resection area: 60 Gy; R2 resection area: 66-70 Gy (silver clip position), once daily.
Gemcitabine (G): Intravenous infusion of 1000 mg/m2 for more than 30 minutes, administered on day 1 and day 8, repeated every 21 days. Capecitabine (X): 1660-2000mg/m2 per day, taken orally in two divided doses, from day 1 to day 14, repeated every 21 days as one cycle. Administration for 6 cycles, every 3 weeks .
Time frame: From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months
Defined as the time from random assignment to the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first)
Time frame: From date of randomization until death from any cause or last follow-up, assessed up to 24 months
The time from random assignment to death due to any cause.
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Cancer Institute and Hospital
Other
A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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