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Esophageal CancerPhase 2NCT00319735

Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas

A Phase 2 study testing Radiation Therapy, Surgery and Tissue Sample in people with Esophageal Cancer, run by Nasser Hanna, M.D. at 7 sites 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

The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Radiation Therapy, Surgery and Tissue Sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
7 sitesUnited States
Study dates
Apr 2006to Jan 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
  • Clinical stage IIA, IIB or III without metastatic disease
  • Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC
  • Patients must be surgical candidates as determined by surgical consult.
  • Patients must agree to surgery.
  • ECOG performance status 0 or 2
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  • Absolute neutrophil count (ANC) > 1,000 mm3
  • Platelet count > 75,000 mm3· Hemoglobin > 10g/dL
  • Bilirubin < 2.5 X upper limit of normal
  • AST (SGOT) or ALT (SGPT) < 5.0 ´ upper limit of normal
  • Creatinine < 2.0 X upper limit of normal

Who cannot join

  • No history of or current brain metastasis.
  • No significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging.
  • No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
  • No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction
  • No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors).
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  • No prior severe infusion reaction to a monoclonal antibody.
  • No major surgery within 28 days prior to being registered for protocol therapy.
  • No clinically significant infections as judged by the treating investigator.
  • No acute hepatitis or known HIV.
  • No other active malignancies.
  • Negative pregnancy test.
  • No female patients currently breastfeeding.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Community Regional Cancer Center

    Indianapolis, Indiana, 46256

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • AP&S Clinic

    Terre Haute, Indiana, 47804

Other trials in United States

About this study

Official title: A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)

The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation.

This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.

Read the detailed description

OUTLINE: This is a multi-center study.

  • Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)
  • Cetuximab 250 mg/m2 IV over 60 minutes, day -7.
  • Cetuximab 250 mg/m2 IV over 60 minutes, days 1, 8, 15, 22, 29 and 36.
  • External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks.
  • Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy.
  • For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of cetuximab, and at the time of surgery for pathology submission.
Being tested
Radiation Therapy, Surgery, Tissue Sample
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Radiation TherapyProcedure or surgery

    External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

  • SurgeryProcedure or surgery

    Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

  • Tissue SampleProcedure or surgery

    For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission

Study groups in NCT00319735
Study groupRoleWhat they receive
Investigational TreatmentExperimental* Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) * Cetuximab 250 mg/m2 IV over 60 minutes Day -7 * Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 * Combined with radiation therapy for six weeks. * Surgery for esophageal resection after 6 to 8 week rest period. Subjects who consent will provide tissue samples.
Receives: Procedure: Radiation Therapy; Procedure: Surgery; Procedure: Tissue Sample

What is being measured

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

  1. Complete Pathologic Response (pCR)

    To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas.

    Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.

    Measured: 36 months

Secondary outcomes (9)

  1. Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.

    To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy.

    Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.

    Measured: Up to 36 months

  2. Time to Relief of Dysphagia

    To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab

    Measured: 36 months

  3. Evaluate Toxicity

    To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

  4. Perform Exploratory Molecular Correlates.

    To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.

    Measured: 36 months

  5. Complete and Partial Response Rate for Patients by Disease Stage: IIA

    To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

  6. Complete and Partial Response Rate for Patients by Disease Stage: IIB

    To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

  7. Complete and Partial Response Rate for Patients by Disease Stage: III

    To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

  8. Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma

    To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

  9. Complete and Partial Response Rate for Patients by Histology: Squamous Cell

    To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas

    Measured: 36 months

Timeline

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

  1. First posted27 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJan 2009
  4. Study completionJan 2009

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00319735
Sponsor's protocol ID
HOG GI05-92
Status last verified
Mar 2016
First submitted
27 Apr 2006
Last updated
28 Apr 2016
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Becerra CR, Hanna N, McCollum AD, Becharm N, Timmerman RD, DiMaio M, Kesler KA, Yu M, Yan T, Choy H. A phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G05-92. J Thorac Oncol. 2013 Nov;8(11):1425-9. doi: 10.1097/JTO.0b013e3182a46c3b.

    PubMed 24084441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy, Surgery and Tissue Sample in people with Esophageal Cancer, run by Nasser Hanna, M.D. at 7 sites 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?

The sponsor lists 11 inclusion and 13 exclusion criteria. 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 28 Apr 2016). 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?

Complete Pathologic Response (pCR) (time frame: 36 months). 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 NCT00319735, which also lists 1 linked publication.

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 28 Apr 2016.

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