Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Esophageal Cancer |
Drug: Capecitabine (Xeloda) Drug: [18-F] Fluorodeoxyglucose (FDG) Drug: 5-Fluorouracil (5-FU) Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion. [ Time Frame: unknown ] [ Designated as safety issue: No ]
- 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
- Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation. [ Time Frame: after completion of their neoadjuvant chemoradiation ] [ Designated as safety issue: No ]
- Physical exam [ Time Frame: Once every three months for two years, then every six months for three years and then once a year. ] [ Designated as safety issue: No ]
- CT scan [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Upper endoscopy [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Patterns of failure and the 2-year progression-free survival (PFS) rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
-
Drug: Capecitabine (Xeloda)
- 5-Fluorouracil
- Carac
- Efudix
- Efudex
- Fluoroplex
- cis-Diammine
- Paraplatin
- Paraplatin-AQ
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Daniel T Chang | Stanford University |
More Information
No publications provided
| Responsible Party: | Daniel T. Chang, PI, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00368329 History of Changes |
| Other Study ID Numbers: | ESOPH0001, 96075 |
| Study First Received: | August 22, 2006 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Fluorouracil Capecitabine Deoxyglucose Carboplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013