A Phase 2 interventional study of capecitabine and gemcitabine hydrochloride in Pancreatic Cancer, sponsored by Lisette Nixon. Completed at 26 sites in United Kingdom. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Lisette Nixon · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. It is not yet known which regimen of chemotherapy given together with radiation therapy is more effective in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of gemcitabine and capecitabine given together with radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
OBJECTIVES:
OUTLINE: This is a multicenter study.
All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Following the first induction therapy, patients with a WHO performance status of 0-1 who are responding or have stable disease that can be encompassed within a radically treatable radiotherapy volume are randomized to 1 of 2 treatment arms.
Arm I:
Arm II:
Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks.
After completion of study treatment, patients are followed every 3 months.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 114 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Lisette Nixon is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit for surgery) disease
PATIENT CHARACTERISTICS:
Must meet the following additional criteria for randomization:
PRIOR CONCURRENT THERAPY:
GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po) followed by gemcitabine 300mg/m2 weekly (IV) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday)
Drug: capecitabine · Drug: gemcitabine hydrochloride · Procedure: quality-of-life assessment · Radiation: 3-dimensional conformal radiation therapy
GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po), followed by capecitabine 830mg/m2 bd (po, Mon-Fri) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday)
Drug: capecitabine · Drug: gemcitabine hydrochloride · Procedure: quality-of-life assessment · Radiation: 3-dimensional conformal radiation therapy
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Time frame: Assessed 39 weeks from registration
Toxicity according to NCI CTCAE v.3.0
Time frame: Assessed throughout trial treatment and follow-up
Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks
Time frame: Assessed throughout trial treatment and follow-up
Overall survival at 52 weeks and time from registration to death by any cause
Time frame: Assessed 52 weeks post registration and during NHS flagging
Objective disease response according to RECIST criteria
Time frame: 39 weeks post registration
Progression-free survival (time to event) according to RECIST criteria
Time frame: Assessed during NHS flagging at the end of the trial
Radiotherapy quality assurance (adherence to protocol)
Time frame: Upon completion of the trial
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lisette Nixon