Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335543
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2006-06-08
Brief Title:
Gemcitabine Cisplatin and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
Sponsor:
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer
PURPOSE This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery
PURPOSE This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride cisplatin and radiotherapy is better than immediate surgery in terms of median survival in patients with locally resectable adenocarcinoma of the pancreatic head
Secondary
Compare 3-year survival rate in patients treated with these regimens
Compare R0 resection rate in these patients
Compare the rate of medium and high toxicity events in these patients
Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
Compare the rate of different regression gradings in resected tumor specimens
Compare the quality of life of these patients
OUTLINE This is a prospective randomized controlled open-label multicenter study Patients are stratified according to participating center and staging laparoscopy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 22 and 29 Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor Approximately 6 weeks after finishing chemoradiotherapy patients with no evidence of disease progression undergo surgery to remove the tumor
Arm II Patients undergo surgery to remove the tumor After surgery all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of chemotherapy and before surgery arm I and then at 6 weeks 6 months 12 months and 24 months after surgery
After completion of study treatment patients are followed every 3 months for 2 years and then at 3 years
PROJECTED ACCRUAL A total of 254 patients will be accrued for this study
Primary
Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride cisplatin and radiotherapy is better than immediate surgery in terms of median survival in patients with locally resectable adenocarcinoma of the pancreatic head
Secondary
Compare 3-year survival rate in patients treated with these regimens
Compare R0 resection rate in these patients
Compare the rate of medium and high toxicity events in these patients
Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
Compare the rate of different regression gradings in resected tumor specimens
Compare the quality of life of these patients
OUTLINE This is a prospective randomized controlled open-label multicenter study Patients are stratified according to participating center and staging laparoscopy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 22 and 29 Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor Approximately 6 weeks after finishing chemoradiotherapy patients with no evidence of disease progression undergo surgery to remove the tumor
Arm II Patients undergo surgery to remove the tumor After surgery all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of chemotherapy and before surgery arm I and then at 6 weeks 6 months 12 months and 24 months after surgery
After completion of study treatment patients are followed every 3 months for 2 years and then at 3 years
PROJECTED ACCRUAL A total of 254 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN78805636 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000472206 | REGISTRY | None | None |
| EU-20609 | None | None | None |