Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2009 |
| Contact: | Kyung Chu, RN |
| Email: | kc2113@columbia.edu |
| Phone: | 212-305-9467 |
Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma
This study is for patients with locally advanced pancreatic cancer (cancer that involves the
local blood vessels so it cannot be removed without cutting major blood vessels) that cannot
be treated with surgery. The purpose of this study is to assess the safety and benefit of 6
three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and
docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with
only venous involvement. Group II patients have arterial involvement and may also have
venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2
weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and
radiation treatment, participants may be able to have surgery to remove any remaining
pancreatic cancer.
local blood vessels so it cannot be removed without cutting major blood vessels) that cannot
be treated with surgery. The purpose of this study is to assess the safety and benefit of 6
three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and
docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with
only venous involvement. Group II patients have arterial involvement and may also have
venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2
weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and
radiation treatment, participants may be able to have surgery to remove any remaining
pancreatic cancer.
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue
should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16
mutations.)
- Locally advanced disease determined by Endoscopic ultrasound, CT scan
(chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET
scan.
- No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast),
MRI scan (of abdomen with gadolinium) or PET scan.
- Unresectable tumor. (this reflects those patients whose tumors abut, invade or
surround a major vessel, either venous or arterial or both)
- No prior chemotherapy or radiation therapy.
- Ineligible for other high priority national or institutional studies.
- Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant,
non-menopausal females.
- Must not have other underlying medical conditions that would make them ineligible for
surgery, radiation therapy, or chemotherapy.
- Complete Blood Count and Complete Metabolic Profile:
Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count >
100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin
> 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN
- Informed consent: Each patient must be completely aware of the nature of his/her
disease process and must willingly give consent after being informed of the nature of
this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
We found this trial at
1
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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