Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal Carcinoma
1 other identifier
interventional
126
1 country
1
Brief Summary
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared. Objectives: Primary objective: Compare the Pathologic Complete Response rate and % of patients with \<50% residual cancer in the resected surgical specimen between Arms A and B. Secondary objectives:
- 1.Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
- 2.Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
- 3.Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
February 9, 2015
CompletedFebruary 9, 2015
January 1, 2015
7.9 years
September 4, 2007
January 27, 2015
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response Rate
Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) \<50% of residual cells in the surgical specimen; or 3) \>50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.
Surgery post chemotherapy (approximately 10-11 weeks)
Study Arms (2)
Arm A: Chemo with Radiation Treatment
EXPERIMENTALFor 5 weeks, Chemo of 5-FU 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
Arm B: Pre-Op Chemo + Chemo with Radiation Treatment
EXPERIMENTALPre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
Interventions
Arm A = 250 mg/m\^2 IV over 24 hours for 5 days weekly for 5 weeks. Arm B = 2.2 mg/m\^2 IV over 48 hours on days 1 and 15.
Arm A: 40 mg/m\^2 IV daily over 2 hours for 5 weeks Arm B: 100 mg/m\^2 IV on Day 1 and 15
Radiation treatment every weekday for 5 weeks.
Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
Eligibility Criteria
You may qualify if:
- Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
- Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
- Normal liver (serum glutamic-pyruvic transaminase (SGPT) \< 56µL, Total Bilirubin \<1.5 mg/dL), kidney (Creatinine \<1.75 mg/dL), and bone marrow functions (AGN \>1,500µL, platelet count \>100,000/µL).
- Performance status 0 or 1.
- Signed informed consent by the investigator or their designee and patient.
- Medically fit for surgery.
- No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.
- None of the celiac nodes should be larger than 2 cm
- Male or Female but both sexes must practice adequate contraception while on therapy
- \>/=18 years but less than 76 years
- No known allergy to any of the study drugs.
- No prior therapy for this cancer.
- No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years
- New York Heart Association (NYHA) I and II
You may not qualify if:
- Patients with T1N0, T4, or M1b cancer will be excluded
- Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
- More than grade 1 neuropathy
- Unable to comprehend the requirements of the study or comply with it.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Sanoficollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (3)
Shimodaira Y, Slack RS, Harada K, Chen HC, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Blum MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Mares J, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Influence of induction chemotherapy in trimodality therapy-eligible oesophageal cancer patients: secondary analysis of a randomised trial. Br J Cancer. 2018 Feb 6;118(3):331-337. doi: 10.1038/bjc.2017.423. Epub 2017 Dec 12.
PMID: 29235564DERIVEDHarada K, Wang X, Shimodaira Y, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Lopez A, Blum Murphy MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Early Metabolic Change after Induction Chemotherapy Predicts Histologic Response and Prognosis in Patients with Esophageal Cancer: Secondary Analysis of a Randomized Trial. Target Oncol. 2018 Feb;13(1):99-106. doi: 10.1007/s11523-017-0540-3.
PMID: 29218623DERIVEDAjani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.
PMID: 23975663DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jaffer Ajani, MD / Professor, GI Medical Oncology
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jaffer Ajani, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 6, 2007
Study Start
April 1, 2005
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 9, 2015
Results First Posted
February 9, 2015
Record last verified: 2015-01