A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study
While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies. In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow. Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review). The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT - carboplatin and paclitaxel - concurrent with upfront pelvic IMPT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist)
whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
Maryland Proton Treatment Center
Baltimore, Maryland, United States
UMMC
Baltimore, Maryland, United States
Central Maryland Radiation Oncology
Columbia, Maryland, United States
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States
Compliance rates
This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT
Time frame: End of study, approximately 4 years
Acute GI and urinary toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events)
Time frame: once a week during radiation treatment (5-6 weeks)
Acute GI and urinary toxicity
Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)
Time frame: once a week during radiation treatment (5-6 weeks)
Acute GI and urinary toxicity
Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain
Time frame: once a week during radiation treatment (5-6 weeks)
Acute hematologic toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events)
Time frame: Prior to each cycle of chemotherapy (once every 21 days for 106 days)
Late GI and urinary toxicity
Measured by CTCAE (Common Terminology Criteria for Adverse Events)
Time frame: 6-month following radiation therapy
Late GI and urinary toxicity
Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)
Time frame: 6-month following radiation therapy
Late GI and urinary toxicity
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Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain
Time frame: 6-month following radiation therapy