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CompletedNCT00470184Updated Nov 25, 2013Results posted

Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

A Phase 2 interventional study of capecitabine and oxaliplatin in Esophageal Cancer, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the complete pathologic response (complete response [CR]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, and radiotherapy.

Secondary

  • Determine the clinical efficacy and toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.
  • Identify basal expression and changes in gene expression that relate to CR, relapse, and survival of patients treated with this regimen.

OUTLINE:

  • Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on the same days they undergo radiotherapy.
  • Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who are eligible undergo esophagectomy.
  • Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene expression studies, microarray analysis, and real-time quantitative reverse transcriptase-PCR to identify basal expression and changes in gene expression.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 41 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus

    • Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
    • Bulk of gastroesophageal junction tumor should be in the esophagus
  • Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 4 months
  • WBC > 4,000/mm³
  • ANC > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • Bilirubin normal
  • Creatinine normal
  • AST \< 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Able to take oral medication or undergo enteral administration of medication
  • No peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 90 days after completion of study treatment
  • No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy

  • No concurrent uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would preclude study compliance

  • No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer

    • Other cured tumors allowed at discretion of the principal investigator
  • No known HIV or hepatitis B or C (active and/or previously treated)

PRIOR CONCURRENT THERAPY:

  • No prior therapy for esophageal cancer
  • No other concurrent investigational agents
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Chemo

    Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy

    Drug: capecitabine · Drug: oxaliplatin · Genetic: gene expression analysis · Genetic: microarray analysis · Genetic: reverse transcriptase-polymerase chain reaction · Procedure: adjuvant therapy · Procedure: biopsy · Procedure: conventional surgery · Procedure: neoadjuvant therapy · Procedure: quality-of-life assessment · Radiation: radiation therapy

Interventions

  • Drugcapecitabine

    Oral

  • Drugoxaliplatin

    IV

  • Geneticgene expression analysis

    Correlative Study

  • Geneticmicroarray analysis

    Correlative Study

  • Geneticreverse transcriptase-polymerase chain reaction

    Correlative Study

  • Procedureadjuvant therapy

    Metastatic growth control

  • Procedurebiopsy

    Examination of tissue type

  • Procedureconventional surgery

    Tissue removal

  • Procedureneoadjuvant therapy

    Tumor shrinkage

  • Procedurequality-of-life assessment

    Correlative Study

  • Radiationradiation therapy

    Undergoing radiation therapy

06

What researchers measure

Primary outcomes

  1. Complete Response

    Time frame: 5.5 weeks

Secondary outcomes

  1. Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1

    Time frame: 5.5 weeks

  2. Median Time to Progression

    Time frame: 5.5 weeks

  3. Quality of Life Improved Rate

    Time frame: 5.5 weeks

07

Results

Posted Nov 25, 2013

Participant flow

Participant flow — Overall Study
MilestoneCOR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Started41
Treated with study therapy36
Completed19
Not completed22
Withdrew: Not treated(became ineligible)4
Withdrew: Not treated (other)1
Withdrew: Disease progression4
Withdrew: Adverse event3
Withdrew: Withdrawal by subject4
Withdrew: Other5
Withdrew: Recurrence1

Outcome measures

PrimaryComplete Response
Time frame:
5.5 weeks
Reported as:
Number · percentage of patients
Complete Response
percentage of patientsCOR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Complete Response27.78 (14.20 to 45.19)
SecondaryOverall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1
Time frame:
5.5 weeks
Reported as:
Number · percentage of patients
Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1
percentage of patientsCOR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy
Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 158.33 (40.76 to 74.49)
SecondaryMedian Time to Progression
Time frame:
5.5 weeks
Reported as:
Number · months
Median Time to Progression
monthsCOR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy
Median Time to ProgressionNA (25.1 to NA)
SecondaryQuality of Life Improved Rate
Time frame:
5.5 weeks
Reported as:
Number · percentage of patients
Quality of Life Improved Rate
percentage of patientsCOR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy
Quality of Life Improved Rate66.67 (49.03 to 81.44)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy—12/36 (33.3%)36/36 (100%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventCOR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Pulmonary embolism - Grade 4Respiratory, thoracic and mediastinal disorders3/36
Oesophagitis - Grade 3Gastrointestinal disorders2/36
Anastomotic leak - Grade 3Injury, poisoning and procedural complications2/36
Pericardial effusion - Grade 3Cardiac disorders1/36
Pericarditis - Grade 2Cardiac disorders1/36
Intestinal obstruction - Grade 3Gastrointestinal disorders1/36
Oesophageal fistula - Grade 3Gastrointestinal disorders1/36
Small intestinal stenosis - Grade 3Gastrointestinal disorders1/36
Death - Grade 5General disorders1/36
Fatigue - Grade 3General disorders1/36
Most frequent other events
Showing 10 of 269
Most frequent other events
EventCOR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Lymphopenia - Grade 2Blood and lymphatic system disorders33/36
Lymphopenia - Grade 1Blood and lymphatic system disorders30/36
Aspartate aminotransferase increased - Grade 1Investigations28/36
Fatigue - Grade 1General disorders27/36
Haemoglobin - Grade 1Investigations26/36
Platelet count decreased - Grade 1Investigations26/36
Lymphopenia - Grade 3Blood and lymphatic system disorders25/36
Diarrhoea - Grade 1Gastrointestinal disorders23/36
Nausea - Grade 1Gastrointestinal disorders23/36
Peripheral sensory neuropathy - Grade 1Nervous system disorders23/36

Baseline characteristics

treated patients

Age Continuous
Age Continuous(years)COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Mean59.53 ± 10.06
Sex: Female, Male
Sex: Female, Male(Participants)COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Female5
Male31
08

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00470184
Lead sponsor
Roswell Park Cancer Institute
Collaborators
National Comprehensive Cancer Network
Responsible party
Sponsor
First posted
May 7, 2007
Start date
Nov 2006
Primary completion
Oct 2012
Results posted
Nov 25, 2013
Last update
Nov 25, 2013

Study contacts

Nikhil Khushalani, MD
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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