RECRUITINGPhase 3INTERVENTIONAL
Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer
Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy
About This Trial
The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy.
Who May Be Eligible (Plain English)
Who May Qualify:
- Ability to understand and the willingness to sign a written willing to sign a consent form document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- diagnosed by tissue sample (biopsy-confirmed) advanced pancreas adenocarcinoma.
- Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.
- Locally advanced pancreatic cancer.
- Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .
- Presence of at least of one measurable lesion in agreement to RECIST criteria.
- The expected survival ≥ 3 months.
- Adequate organ performance based on laboratory blood tests.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Who Should NOT Join This Trial:
- Pregnant or nursing women.
- Primary pancreatic cancer.
- Baseline serum CA19-9 ≤ 37 U/mL.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- Renal insufficiency or dialysis
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- Patients who are allergic to oxaplatin or other chemotherapy drugs.
- Patients who are unwilling or unable to comply with study procedures.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥ 18 years and ≤ 80 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
* Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.
* Locally advanced pancreatic cancer.
* Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* The expected survival ≥ 3 months.
* Adequate organ performance based on laboratory blood tests.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria:
* Pregnant or nursing women.
* Primary pancreatic cancer.
* Baseline serum CA19-9 ≤ 37 U/mL.
* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
* Renal insufficiency or dialysis
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
* Patients who are allergic to oxaplatin or other chemotherapy drugs.
* Patients who are unwilling or unable to comply with study procedures.
Treatments Being Tested
DRUG
Gemcitabine, Nab-paclitaxel, Irinotecan
continuing chemotherapy using the previous regimen until disease progression
RADIATION
Intensity-Modulated Radiation Therapy (IMRT)
Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy.
Locations (1)
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China