Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 12
Summary
- Conditions
- Adenocarcinoma, Esophageal
- Adenocarcinoma, Gastroesophageal Junction
- Esophageal Cancer
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction. RESEARCH PLAN Phase III randomized 2-arm parallel group pilot study 1:1 randomization to ...
OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction. RESEARCH PLAN Phase III randomized 2-arm parallel group pilot study 1:1 randomization to A) or B) TREATMENT REGIMEN A) PERIOPERATIVE CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively: 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days OR 2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,) day 1 IV Cisplatin: 60 mg/m², day 1 IV 5-Fluorouracil: 200 mg/m², daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, BID (ECX) OR B) NEOADJUVANT CHEMORADIATION 1) -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 paclitaxel: 50 mg / m2 IV carboplatin: dosed to an area under the curve of 2, by Calvert formula Radiation Therapy 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk Upon completion of neoadjuvant therapy, all patients will be considered for surgery. Patients will be deemed acceptable for surgery provided: repeat imaging performed after neoadjuvant therapy does not demonstrate distant metastases or local invasion of the primary tumor into vital structures (heart, great vessels, trachea) maintenance of adequate performance status and ability to tolerate esophagectomy Surgery will be performed preferably within 8 weeks of completion of neoadjuvant therapy.
Tracking Information
- NCT #
- NCT01404156
- Collaborators
- CancerCare Manitoba
- University of Toronto
- London Health Sciences Centre
- Investigators
- Principal Investigator: Gordon Buduhan, MD MSc FRCSC University of Manitoba / CancerCare Manitoba