FOLFIRINOX + RT for Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | May 2012 |
| End Date: | January 2019 |
Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer
This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.
"Investigational" means that the therapy is still being studied and that research doctors are
trying to find out more about it-such as the safest dose to use, the side effects it may
cause, and if therapy is effective for treating different types of cancer. Proton beam
radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery
system.
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as
it delivers less radiation beyond the area of the target tissues. This may reduce side
effects that patients would normally experience with standard (photon) radiation therapy,
which tends to include more normal tissue along with tumor target tissue.
Researchers in the laboratory have discovered that there are pathways inside the cells that
can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and
capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,
and may result in the tumor shrinking in size.
In this research study, the investigators are looking to determine if proton beam radiation
in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of
your cancer.
effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.
"Investigational" means that the therapy is still being studied and that research doctors are
trying to find out more about it-such as the safest dose to use, the side effects it may
cause, and if therapy is effective for treating different types of cancer. Proton beam
radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery
system.
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as
it delivers less radiation beyond the area of the target tissues. This may reduce side
effects that patients would normally experience with standard (photon) radiation therapy,
which tends to include more normal tissue along with tumor target tissue.
Researchers in the laboratory have discovered that there are pathways inside the cells that
can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and
capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,
and may result in the tumor shrinking in size.
In this research study, the investigators are looking to determine if proton beam radiation
in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of
your cancer.
For weeks 1-8, you will only be receiving FOLFIRINOX via IV infusion. The treatment plan will
begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14 days long. You will receive
FOLFIRINOX therapy on days 1, 2 and 3 of each of the four cycles. The FOLFIRINOX treatment is
broken up into three different drugs. 5-FU will be administered over two hours on day one of
each cycle, and then continuously with a pump for days 2 and 3. Oxaliplatin will be delivered
by intravenous (infusion) over 120 minutes. Irinotecan will be given by IV for 90 minutes.
All parts of this treatment will be received as an outpatient.
If after 4 cycles of FOLFIRINOX therapy, your tumor has not spread, you will receive a
further 4 cycles of FOLFIRINOX. If after 8 total cycles of FOLFIRINOX your cancer is clearly
resectable, you will proceed to phase 2 of treatment with capecitabine and radiation therapy.
You will take tablets of capecitabine by mouth for a total of 10 days (Monday through Friday)
during the two weeks after your FOLFIRINOX treatment.
You will be given a drug diary for capecitabine which contains instructions on how to take
the drug.
Short course radiation: You will receive proton radiation treatment for five days (Monday
through Friday) after your FOLFIRINOX treatment, during the time of your capecitabine
treatment, or photon radiation for ten days (Monday through Friday for two weeks). You will
also be assessed at least once during this treatment course for any side effects you may be
experiencing.
You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton
Center or the Clark Center for Radiation Oncology at the Massachusetts General Hospital
Surgery is expected to occur approximately one to four weeks after completion of capecitabine
therapy.
After your surgery, you may receive additional chemotherapy at the discretion of your
treating physician and be followed as per standard of care.
begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14 days long. You will receive
FOLFIRINOX therapy on days 1, 2 and 3 of each of the four cycles. The FOLFIRINOX treatment is
broken up into three different drugs. 5-FU will be administered over two hours on day one of
each cycle, and then continuously with a pump for days 2 and 3. Oxaliplatin will be delivered
by intravenous (infusion) over 120 minutes. Irinotecan will be given by IV for 90 minutes.
All parts of this treatment will be received as an outpatient.
If after 4 cycles of FOLFIRINOX therapy, your tumor has not spread, you will receive a
further 4 cycles of FOLFIRINOX. If after 8 total cycles of FOLFIRINOX your cancer is clearly
resectable, you will proceed to phase 2 of treatment with capecitabine and radiation therapy.
You will take tablets of capecitabine by mouth for a total of 10 days (Monday through Friday)
during the two weeks after your FOLFIRINOX treatment.
You will be given a drug diary for capecitabine which contains instructions on how to take
the drug.
Short course radiation: You will receive proton radiation treatment for five days (Monday
through Friday) after your FOLFIRINOX treatment, during the time of your capecitabine
treatment, or photon radiation for ten days (Monday through Friday for two weeks). You will
also be assessed at least once during this treatment course for any side effects you may be
experiencing.
You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton
Center or the Clark Center for Radiation Oncology at the Massachusetts General Hospital
Surgery is expected to occur approximately one to four weeks after completion of capecitabine
therapy.
After your surgery, you may receive additional chemotherapy at the discretion of your
treating physician and be followed as per standard of care.
Inclusion Criteria:
- Cytologic or histologic proof pancreatic ductal carcinoma
- Borderline resectable
- Life expectancy of at least 3 months
- ECOG Performance Status ≤ 1
- Adequate organ and bone marrow function
- No treatment of other invasive cancers within the last 5 years with greater than 5%
risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal
cell carcinoma/squamous cell carcinoma of the skin are allowed
- > 4 weeks since major surgery, excluding laparoscopy
Exclusion Criteria:
- Evidence of metastatic disease
- Pregnant or breastfeeding
- Other serious uncontrolled medical conditions
- Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the
pancreatic tumor
- Prior systemic fluoropyrimidine therapy
- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability
- Individuals on cimetidine
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Theodore Hong, MD
Phone: 617-724-1700
Click here to add this to my saved trials
