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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.
Full description
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.
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Inclusion criteria
Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm respectively.
ECOG performance status ≤ 2
Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
Age ≥ 18 and ≤ 80.
Adequate hematological, renal, hepatic and pulmonary function as defined by:
Patients capable of childbearing are using adequate contraception.
Written and informed consent of patient.
Exclusion criteria
Primary purpose
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Interventional model
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42 participants in 1 patient group
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Central trial contact
Amy Abel; Sanjune Laurence Lee, MD
Data sourced from clinicaltrials.gov
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