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Esophageal CancerPhase 2NCT00711412

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

A Phase 2 study testing Induction Therapy - Capecitabine, Induction Therapy - Oxaliplatin and Combination Therapy - Capecitabine in people with Esophageal Cancer, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Induction Therapy - Capecitabine, Induction Therapy - Oxaliplatin and Combination Therapy - Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
31 May 2006to 30 Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
  • Stage I-IVA disease
  • No distant metastatic disease (other than regional lymph nodes)
  • No evidence of CNS metastases
  • CNS metastases stable for > 3 months allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Consuming ≥ 1,500 calories daily
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing neuropathy
  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No known hypersensitivity to fluorouracil
  • No known DPD deficiency
  • No known hypersensitivity to any of the components of oxaliplatin
  • No significant active infection or other severe complicated medical illness
  • No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
  • No myocardial infarction within the past 12 months
  • No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
  • No malabsorption syndrome
  • No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior participation in any investigational drug study
  • No prior pelvic or thoracic radiotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

Other trials in United States

About this study

Official title: A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 and 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 capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.

Secondary

  • Determine the clinical response rate in patients treated with this regimen.
  • Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
  • Characterize the toxicity profile of this regimen in these patients.

OUTLINE:

  • Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity.
  • Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months.

Being tested
Induction Therapy - Capecitabine, Induction Therapy - Oxaliplatin, Combination Therapy - Capecitabine, Combination Therapy - Oxaliplatin, Combination Therapy - Radiation
Keywords
adenocarcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induction Therapy - CapecitabineDrug

    Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.

  • Induction Therapy - OxaliplatinDrug

    Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.

  • Combination Therapy - CapecitabineDrug

    Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.

  • Combination Therapy - OxaliplatinDrug

    Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.

  • Combination Therapy - RadiationRadiation

    1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

  • Evaluation for response and surgeryProcedure or surgery

    Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.

Study groups in NCT00711412
Study groupRoleWhat they receive
Induction, Combination and surgeryExperimentalWeeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8 Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday Evaluation for response and resection surgery
Receives: Drug: Induction Therapy - Capecitabine; Drug: Induction Therapy - Oxaliplatin; Drug: Combination Therapy - Capecitabine; Drug: Combination Therapy - Oxaliplatin; Radiation: Combination Therapy - Radiation; Procedure: Evaluation for response and surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine Pathologic Complete Response

    Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.

    Pathologic response will be defined as:

    P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer

    Measured: At time of surgery

Secondary outcomes (6)

  1. Clinical Response Rate

    Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .

    Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD

    Measured: four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery

  2. Recurrence Rate

    Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.

    Measured: From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.

  3. Time to Progression

    Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.

    Measured: From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.

  4. Patterns of Failure

    Measured: At time of surgery

  5. Toxicity Profile

    Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)

    In general adverse events (AEs) will be graded according to the following:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

    Only incidents of AEs determined to be related to chemotherapy are recorded here.

    Measured: During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.

  6. Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.

    Measured: At time of sugery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study start31 May 2006
  3. Primary completion29 May 2009
  4. Study completion30 Jan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711412
Sponsor's protocol ID
NU 05I2
Other IDs
STU00006779
Status last verified
Jul 2018
First submitted
5 Jul 2008
Last updated
18 Jul 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction Therapy - Capecitabine, Induction Therapy - Oxaliplatin and Combination Therapy - Capecitabine in people with Esophageal Cancer, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine Pathologic Complete Response (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.

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