Stereotactic Body Radiation Therapy or Conventionally Fractionated Concurrent Chemotherapy and Radiation Therapy Preoperatively for Resectable or Borderline Resectable Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03704662|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Stereotactic Body Radiation Therapy Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy||Not Applicable|
RATIONALE: There are limited studies comparing novel radiation treatments with stereotactic body radiation therapy (SBRT) in pancreatic adenocarcinoma to conventional fractionation. Much of the existing literature indicates this technique is safe and convenient for patients, as compared with conventionally fractionated concurrent chemo-radiation therapy. However, there has been no direct comparison of these two treatment modalities when given in the preoperative setting. It also remains uncertain if SBRT results in similar nodal downstaging to preoperative, conventionally fractionated chemo-RT.
STUDY DESIGN: This study is a prospective, open-label, randomized, parallel, two-arm, phase II clinical trial. Patients meeting the eligibility criteria will be randomized after a minimum of two months of induction chemotherapy. These patients will be required to have no biopsy-proven distant disease on repeat staging studies before randomization. Patients who have radiologically equivocal evidence of distant metastatic disease (small lung nodules, or liver lesions that cannot be definitively characterized, etc.) are also eligible for enrollment. Patients with biopsy-proven metastatic disease are not eligible. The total number of patients planned for accrual is approximately 102 patients (51 patients per arm).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiation Therapy or Conventionally Fractionated Concurrent Chemotherapy and Radiation Therapy Preoperatively for Resectable or Borderline Resectable Pancreatic Adenocarcinoma|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2023|
Stereotactic Body Radiation Therapy
Patients undergo Stereotactic Body Radiation Therapy (SBRT) five days a week for 1.5 weeks.
Radiation: Stereotactic Body Radiation Therapy
Other Name: SBRT
Preoperative Fractionated Radiation Therapy and Chemotherapy
Patients undergo Fractionated Radiation Therapy five days a week for 5.5 weeks, followed by a chemotherapy regimen.
Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy
Conventional concurrent chemotherapy and radiation therapy.
- Percentage of patients with node-positive disease following surgical resection comparison of conventially fractionated chemo RT versus SBRT. [ Time Frame: up to six months. ]We will use a two-sided exact binomial test of proportions to compare the rates of node positivity between the conventional therapy versus the SBRT groups.
- Compare patient-reported quality of life, as measured by the pancreatic cancer-specific QLQ PAN26 questionnaire. [ Time Frame: up to six months after surgery. ]Quality-of-life assessments will be compared between groups, using a two-sided t-test.
- Overall survival. [ Time Frame: Up to 5 years ]We will use the Kaplan-Meier method to estimate this. This will be compared between arms, using the log-rank test.
- Progression-free survival. [ Time Frame: Up to 5 years. ]We will use the Kaplan-Meier method to estimate this. This will be compared between arms, using the log-rank test.
- Compare the proportions of toxic effects between the treatment arms. [ Time Frame: Up to 2 years. ]We will tabulate the toxicity data by grading it as absent or present at grades 1-4 (NCI CTCAE Version 4 criteria) and compare the scores for both the conventionally fractionated and the SBRT arms, using a chi-squared test.
- Compare surgical complications. [ Time Frame: Assessed at time of surgery and up to six weeks following. ]This will be measured by the measured by the Clavien-Dindo Complications Score, unexpected surgical complications and blood loss. The scale has 5 grades with 2 further subdivided. Grade 1: Any deviation from the normal postoperative course w/o the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutrition included. Grade 3: Requiring surgical, endoscopic or radiological intervention. Grade 3a: Intervention not under general anesthesia. Grade 3b: Intervention under general anesthesia. Grade 4: Life-threatening complication (including CNS complications) requiring IC/ICU-management. Grade 4a: single organ dysfunction (including dialysis). Grade 4b: multiorgandysfunction. Grade 5: Death.
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): NCT03704662
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officefirstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Hospital & Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 email@example.com|
|Principal Investigator:||William Hall, MD||Medical College of Wisconsin|