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Esophageal NeoplasmsPhase 1NCT00368329

Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer

A Phase 1 study testing Capecitabine (Xeloda), [18-F] Fluorodeoxyglucose (FDG) and 5-Fluorouracil (5-FU) in people with Esophageal Neoplasms and Carcinoma, Squamous Cell, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine (Xeloda), [18-F] Fluorodeoxyglucose (FDG) and 5-Fluorouracil (5-FU)
Type of treatment
Injection or infusion
How many people
4 participants
Where
1 siteUnited States
Study dates
Jun 2006to Mar 2009
Phase
Phase 1
Are there results?
None posted in the registry

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

Inclusion Criteria:- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist.

  • Endoscopic ultrasound or CT evidence of tumor penetration through the esophageal wall or involvement of regional lymph nodes, without evidence of distant metastasis
  • No prior chest radiation therapy
  • No prior chemotherapy for esophageal cancer
  • Age greater than 18 years
  • No infections requiring antibiotic treatment
  • Able to care for self
  • Patients must have acceptable liver, kidney and bone marrow function.
  • The effects of the chemotherapy drugs on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception. Exclusion Criteria:- Patients receiving any other investigational agents
  • Evidence of distant metastases
  • Uncontrolled medical illness
  • Any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Pregnant and breastfeeding women are excluded.
  • HIV-positive patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer

To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.

Read the detailed description

This study will evaluate the safety and feasibility of delivering radiation dose escalation using hypofractionated radiosurgery in locally advanced esophageal cancer. The dose escalation will be delivered using an image-guided radiosurgical boost to the tumor volume, following a neoadjuvant regimen consisting of oxaliplatin, capecitabine, and conventionally fractionated radiotherapy. In addition, we will evaluate the utility of PET-FDG before and after neoadjuvant chemoradiation in predicting the pathologic response to pre-operative treatment. We will study the effect of this regimen on pathologic complete response rates and complete resection rates at surgery among patients with locally advanced esophageal cancer and determine patterns of failure and rates of progression-free survival. Finally, we plan to characterize in an exploratory manner the correlation between molecular markers and pathologic findings following pre-operative chemoradiation.

Being tested
Capecitabine (Xeloda), [18-F] Fluorodeoxyglucose (FDG), 5-Fluorouracil (5-FU), Carboplatin
Medical subject headings
Esophageal Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma

What participants receive

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

  • Capecitabine (Xeloda)Drug

    Also called Xeloda

    PO bid daily on RT days: 500mg \& 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)

  • [18-F] Fluorodeoxyglucose (FDG)Drug

    Also called Fluorodeoxyglucose

    5-10 mCi IV administration

  • 5-Fluorouracil (5-FU)Drug

    Also called 5-Fluorouracil, Carac, Efudix, Efudex

    200mg/m2 continuous venous infusion

  • CarboplatinDrug

    Also called cis-Diammine, Paraplatin, Paraplatin-AQ

    AUC 2, based onCalvert formula IV infusion

What is being measured

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

  1. A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.

  2. The inked margins on the definitive surgical specimen will be inked and margin status, size of the tumor, evidence of residual tumor will be recorded.

  3. Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.

    Measured: after completion of their neoadjuvant chemoradiation

Secondary outcomes (4)

  1. Physical exam

    Measured: Once every three months for two years, then every six months for three years and then once a year.

  2. CT scan

    Measured: Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.

  3. Upper endoscopy

    Measured: Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.

  4. Patterns of failure and the 2-year progression-free survival (PFS) rate.

    Measured: 2 years

Timeline

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

  1. First posted24 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: low accrual

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368329
Sponsor's protocol ID
ESOPH0001
Other IDs
96075
Status last verified
Jul 2012
First submitted
22 Aug 2006
Last updated
16 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine (Xeloda), [18-F] Fluorodeoxyglucose (FDG) and 5-Fluorouracil (5-FU) in people with Esophageal Neoplasms and Carcinoma, Squamous Cell, run by Stanford 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: stopped early, as of the sponsor's last update on 16 Jul 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

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?

A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.. The study lists 3 primary outcomes in all. 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 NCT00368329.

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 16 Jul 2012.

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