An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.
Patients with carcinoma of the esophagus or gastroesophageal junction who are suitable for curative intent trimodality therapy will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously weekly for 5 weeks. External beam RT in 5 fractions over 1 week will be delivered any time between week 3-5 of chemotherapy. Ideally patients should get radiotherapy during week 3 of chemotherapy but delivery during week 4-5 is permissible with documentation of the minor deviation. RT must start within 30 calendar days of signing the informed consent form. While restaging imaging is done as per institutional guidelines, ideally patients should get a PET/CT 6 weeks post chemoradiotherapy. Patient will then go for esophagectomy 6-12 weeks after the completion of chemoradiotherapy, but ideally at 6-8 weeks post chemoradiotherapy. Patients will be assessed for acute toxicity weekly during neoadjuvant therapy and then biweekly until esophagectomy. One month after surgery, patient will have a final clinical follow up with the radiation oncologist and review any post-operative complications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Hypofractionated radiation 23 Gy in 5 fractions with a simultaneous integrated boost of 26 Gy in 5 fractions to the gross tumor volume (GTV) given concurrently over 1 week during week 3 of chemotherapy.
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
RECRUITINGTo determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy
Tumor regression grades and pathological complete response rates determined after one week of surgery
Time frame: up to the Post-operative visit (60-90 days after surgery)
To determine the rates of acute toxicities
Safety will be determined by recording adverse events as per the CTCAE classification and grading system
Time frame: up to the Post-operative visit (60-90 days after surgery)
To compare pathological response rates to changes in tumor FDG-PET uptake
Changes in tumor FDG-PET standard uptake value and total lesion glycolysis
Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to changes in tumor dimensions
Changes in tumor dimensions on CT
Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to dysphagia scores
Change in dysphagia score, measured at Screening/Baseline and at the Post-operative clinical follow-up
Time frame: up to the Post-operative visit (60-90 days after surgery)
Correlate pre- and post-chemoradiation immune microenvironment composition with the above outcome variables (pathological response, dysphagia scores, changes in FDG-PET uptake and/or tumor dimensions on CT)
Translational correlation between immune infiltration of biopsy and resection specimens with pathological (regression grades and response rates), clinical (dysphagia scores) and imaging (FDG-PET uptake and/or tumor dimensions on CT) outcomes
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Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).