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2009-12
2011-12-30
2011-12-30
10
NCT00889187
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer
The purpose of this research study is to determine if it is possible to deliver high dose radiation in one week while also giving the drug capecitabine for the treatment of pancreatic cancer prior to surgery, to determine if this treatment can be given safely for the treatment of pancreatic cancer prior to surgery and, to determine if this treatment can improve the local control pancreatic cancer prior to surgery compared to historical controls of standard treatment.
OBJECTIVES: Primary * Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule with concurrent capecitabine * Phase II: To demonstrate a grade 3 or greater (any) toxicity rate of less than 20% Secondary * To determine local control and recurrence patterns of pancreatic cancer relative to a standard regimen of 50.4 Gy as seen in historical controls * To determine the pathologic response rate * To determine the progression-free survival * To determine the surgical morbidity * To determine 30-day post-operative mortality after pancreatic resection
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-04-27 | 2017-04-14 | 2018-04-12 |
2009-04-27 | 2017-06-16 | 2018-05-11 |
2009-04-28 | 2017-07-14 | 2018-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Phase 1 Cohort 1: Photon Rad (30 Gy/12 days)+Capecitabine Neoadjuvant Short-Course Photon Radiation: At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days. Chemotherapy: Capecitabine was given orally 825 mg/m2 BID (tot | RADIATION: Neoadjuvant Short-Course Photon Radiation DRUG: Capecitabine |
| EXPERIMENTAL: Phase I Cohort 2: Photon Rad (25 Gy/11 days)+Capecitabine Neoadjuvant Short-Course Photon Radiation: At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days. Chemotherapy: Capecitabine was given orally 825 mg/m2 BID (total 1650 | RADIATION: Neoadjuvant Short-Course Photon Radiation DRUG: Capecitabine |
| EXPERIMENTAL: Phase I Cohort 3: Photon Rad (25 Gy/5 days)+Capecitabine Neoadjuvant Short-Course Photon Radiation: At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days. Chemotherapy: Capecitabine was given orally 825 mg/m2 BID (total 1650 | RADIATION: Neoadjuvant Short-Course Photon Radiation DRUG: Capecitabine |
| EXPERIMENTAL: All Phase I: Photon Rad+Capecitabine Neoadjuvant Short-Course Photon Radiation: All Phase I participants received the radiation regimen according to the established dose escalation schedule. Chemotherapy: Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten conse | RADIATION: Neoadjuvant Short-Course Photon Radiation DRUG: Capecitabine |
| EXPERIMENTAL: Phase II: Photon Rad (MTD)+Capecitabine Neoadjuvant Short-Course Photon Radiation: Phase II participants received the radiation regimen established in the Phase I study (MTD). Chemotherapy: Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, b | RADIATION: Neoadjuvant Short-Course Photon Radiation DRUG: Capecitabine |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I] | Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached. | within 3 weeks of the start of chemoradiation therapy |
| Dose Limiting Toxicity (DLT) [Phase I] | DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT. | within 3 weeks of the start of chemoradiation therapy |
| Grade 3-5 Toxicity Rate [Phase II] | All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms. | within 3 weeks of the start of chemoradiation therapy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local Recurrence Rate [Phase II] | Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5. |
| Pathologic Response Rate [Phase II] | Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist. | Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy |
| Progression-Free Survival (PFS) [Phase II] | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation | Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5. |
| Surgical Morbidity Rate [Phase II] | The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms. | Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy |
| Surgical Mortality Rate [Phase II] | The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite). | Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
