NCT00368329

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

August 22, 2006

Last Update Submit

July 13, 2012

Conditions

Esophageal NeoplasmsCarcinoma, Squamous CellAdenocarcinomaEsophageal Cancer

Outcome Measures

Primary Outcomes (3)

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

  • 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.

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

    after completion of their neoadjuvant chemoradiation

Secondary Outcomes (4)

  • Physical exam

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

  • CT scan

    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.

  • Upper endoscopy

    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.

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

    2 years

Interventions

Capecitabine (Xeloda)DRUG

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

Also known as: Xeloda
[18-F] Fluorodeoxyglucose (FDG)DRUG

5-10 mCi IV administration

Also known as: Fluorodeoxyglucose
5-Fluorouracil (5-FU)DRUG

200mg/m2 continuous venous infusion

Also known as: 5-Fluorouracil, Carac, Efudix, Efudex, Fluoroplex
CarboplatinDRUG

AUC 2, based onCalvert formula IV infusion

Also known as: cis-Diammine, Paraplatin, Paraplatin-AQ

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsCarcinoma, Squamous CellAdenocarcinoma

Interventions

CapecitabineFluorodeoxyglucose F18FluorouracilCarboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDeoxyglucoseDeoxy SugarsCarbohydratesCoordination ComplexesOrganic Chemicals

Study Officials

  • Daniel T Chang

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

US(1)