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Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiation in Patients With Surgically Resectable Esophageal Cancer: a Pilot Randomized Study


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Cancer, Adenocarcinoma, Esophageal, Squamous Cell Carcinoma, Esophageal, Carcinoma, Gastroesophageal Junction

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Trial Information

Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiation in Patients With Surgically Resectable Esophageal Cancer: a Pilot Randomized Study


Inclusion Criteria:



- age < 75 years

- absolute neutrophil count ≥ 1.5 x 109 / L

- platelet count > 100 x 109 / L

- creatinine clearance > 50 ml / min

- bilirubin < 1.5x upper limit normal

- FEV1 > 1.0 L

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- negative serum / urine pregnancy test for females of childbearing age

- no previous primary / recurrent malignancy in last 5 years

- no previous chemotherapy for esophageal cancer

- no previous radiation therapy that would overlap required radiation fields

- no major systemic illness(es) that would limit life expectancy <2 years

- no psychiatric / cognitive illness that would limit ability to give informed consent

- cT1N1 or T2-3Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging
classification(36)

- proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and
extend no greater than 2 cm into the gastric cardia

- tumor length < 8cm; radial size < 5 cm

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

compliance with assigned neoadjuvant treatment

Outcome Description:

- >50% patients allocated for randomization will start and complete treatment without major protocol violation

Outcome Time Frame:

5 weeks for chemoradiation arm, 6 weeks for chemotherapy arm

Safety Issue:

Yes

Authority:

Canada: Health Canada

Study ID:

CDHA 147937-7

NCT ID:

NCT01404156

Start Date:

December 2011

Completion Date:

February 2013

Related Keywords:

  • Esophageal Cancer
  • Adenocarcinoma, Esophageal
  • Squamous Cell Carcinoma, Esophageal
  • Carcinoma, Gastroesophageal Junction
  • Esophageal cancer
  • Neoadjuvant
  • Chemotherapy
  • Chemoradiation
  • Surgery
  • Esophagectomy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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