Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03704662|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : July 21, 2021
|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 one cycle 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), with 14 additional patients enrolled to account for a roughly 15% drop out rate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Clinical Trial of Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||December 1, 2030|
|Estimated Study Completion Date :||December 1, 2032|
Stereotactic Body Radiation Therapy
Patients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions)
Radiation: Stereotactic Body Radiation Therapy
Other Name: SBRT
Preoperative Fractionated Radiation Therapy and Chemotherapy
Concurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions).
Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy
Conventional concurrent chemotherapy and radiation therapy.
- The number of subjects who present with node-positive disease following surgical resection. [ Time Frame: 8 weeks postradiation ]Subjects will undergo surgical resection within three to eight weeks following treatment.
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|