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Neoadjuvant Chemotherapy vs. Chemoradiation for Resectable Esophageal Cancer

This study is currently recruiting participants.
Verified January 2012 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Capital Health, Canada
Information provided by (Responsible Party):
Gordon Buduhan, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01404156
First received: July 26, 2011
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

The best treatment for resectable esophageal cancer is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either chemotherapy or chemotherapy plus radiation (chemoradiation) is given before surgery (preoperative), compared to surgery alone. However it is unknown which of these treatments (preoperative chemotherapy or preoperative chemoradiation) is more effective in improving survival. A study where patients with resectable esophageal cancer are chosen at random to receive one of the two preoperative treatments would help determine if one form of treatment improves survival compared to the other.

Patients with localized esophageal cancer will be randomized to receive either preoperative chemotherapy or preoperative chemoradiation followed by surgery.

The main objective of this pilot trial is to determine the possibility of conducting a larger study with many centers participating. If this study proves to be feasible with enough patients enrolled and able to tolerate treatments without major side effects then we can hopefully proceed to perform a larger multi-center trial to look for survival outcome differences between patients who receive preoperative chemotherapy and those who receive preoperative chemoradiation. The results of this trial would ultimately help us choose the most effective treatment of resectable esophageal cancer and hopefully improve survival.


Condition Intervention Phase
Esophageal Cancer
Adenocarcinoma, Esophageal
Squamous Cell Carcinoma, Esophageal
Carcinoma, Gastroesophageal Junction
 Drug: carboplatin and paclitaxel
Other: Carboplatin paclitaxel plus concurrent radiotherapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiation in Patients With Surgically Resectable Esophageal Cancer: a Pilot Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • compliance with assigned neoadjuvant treatment [ Time Frame: 5 weeks for chemoradiation arm, 6 weeks for chemotherapy arm ] [ Designated as safety issue: Yes ]
    - >50% patients allocated for randomization will start and complete treatment without major protocol violation

  • treatment response [ Time Frame: 5 weeks for chemoradiation arm, 6 weeks for chemotherapy arm ] [ Designated as safety issue: No ]
    >30% of patients in both treatment arms demonstrate partial or complete response as defined by RECIST guidelines on restaging CT PET, and / or Mandard TRG 1-3 on pathologic staging


Secondary Outcome Measures:
  • survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    3 year overall- and disease-free survival

  • quality of life [ Time Frame: baseline, 3, 6, 9, 12 months post treatment ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Version 3.0


Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neoadjuvant Chemotherapy Drug: carboplatin and paclitaxel

2 cycles carboplatin and paclitaxel days 1, 8, 15 given every 4 weeks:

  • paclitaxel: 75 mg / m2 IV in 250 ml normal saline (NS) over 1 hour
  • carboplatin: dosed to an area under the curve of 3, by Calvert formula, as a 1 hour IV infusion
Experimental: Neoadjuvant Chemoradiation Other: Carboplatin paclitaxel plus concurrent radiotherapy

5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29

  • paclitaxel: 50 mg / m2 IV over 1 hour

  • carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion, diluted in 500 ml Dextrose 5% Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.

    1. Dose specifications:

      1. Total radiation prescription dose 45- 50.4 Gy given in 25-28 fractions of 1.8 Gy per fractions, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404156

Contacts
Contact: Gordon Buduhan, MD MSc FRCSC 902-473-8337 gordon.buduhan@cdha.nshealth.ca
Contact: Erin Little 902-473-3735 erin.little@cdha.nshealth.ca

Locations
Canada, Nova Scotia
QEII Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Gordon Buduhan
Capital Health, Canada
  More Information

No publications provided

Responsible Party: Gordon Buduhan, MD MSc FRCSC Assistant Professor of Surgery Division of Thoracic Surgery,, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01404156     History of Changes
Other Study ID Numbers: CDHA 147937-7
Study First Received: July 26, 2011
Last Updated: January 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Esophageal cancer
Neoadjuvant
Chemotherapy
 Chemoradiation
Surgery
Esophagectomy

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Carcinoma, Squamous Cell
Esophageal Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013