Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02243358|
Recruitment Status : Unknown
Verified October 2016 by Gazala Khan, MD, Henry Ford Health System.
Recruitment status was: Recruiting
First Posted : September 17, 2014
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Neoplasm Malignant Resectable||Drug: Folfox6 Drug: Gemcitabine Radiation: Radiation Therapy Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy||Phase 2|
The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing.
Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment.
Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2018|
- Drug: Folfox6
Other Name: 5 Fluoropyrymidine
- Drug: Gemcitabine
Other Name: Gemzar
- Radiation: Radiation Therapy
- Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
- Primary Tumor Response [ Time Frame: 6 weeks ]Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243358
|Contact: Tiffany Pearce, BSemail@example.com|
|Contact: Jennifer Carabio, BSfirstname.lastname@example.org|
|Principal Investigator:||Gazala Khan, MD||Henry Ford Health System|