Trimodality Management of T1b Esophageal Cancers

NCT01217060 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2010-0333NCI-2012-01902
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how long. The safety of this treatment will also be studied.

Conditions

Esophageal Cancer

Keywords

Adenocarcinoma; Squamous cell carcinoma; Thoracic esophagus; Gastroesophageal junction; Chemoradiotherapy; Esophagectomy; 5-Fluorouracil; Docetaxel; Radiation; Radiotherapy; XRT; IMRT; Taxotere; Adrucil; Efudex; Dexamethasone; Decadron

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (PCR) Rate

  The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.

  Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.

Secondary Outcomes (1)

• Disease-free Survival (DFS) Time

  Time to disease progression or death, up to 6 years

Study Arms (1)

Docetaxel + 5-FU + Radiation + Surgery

EXPERIMENTAL

Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.

Drug: Docetaxel; Drug: 5-FU; Radiation: Radiotherapy; Procedure: Esophagectomy; Drug: Dexamethasone

Interventions

Docetaxel DRUG

20 mg/m2 given by vein (IV) over 1 hour once a week for up to 5 1/2 weeks.

Also known as: Taxotere

Docetaxel + 5-FU + Radiation + Surgery

5-FU DRUG

300 mg/m2 given by vein, continuously for 96 hours a week for about 5 1/2 weeks.

Also known as: Adrucil, Efudex, 5-Fluorouracil

Docetaxel + 5-FU + Radiation + Surgery

Radiotherapy RADIATION

50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks, Monday through Friday.

Also known as: Radiation Therapy

Docetaxel + 5-FU + Radiation + Surgery

Esophagectomy PROCEDURE

Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.

Also known as: Surgical Resection

Docetaxel + 5-FU + Radiation + Surgery

Dexamethasone DRUG

10 mg IV 30 minutes prior to weekly Docetaxel.

Also known as: Decadron

Docetaxel + 5-FU + Radiation + Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either criteria # 1 or #2 can be met for eligibility).
• Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established.
• Performance score Karnofsky Performance Scale (KPS) 80-100.
• Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation.
• Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception.
• Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) \>2,500/uL, platelets \> 75,000/uL), renal (creatinine clearance \> 50 mL/min), and liver function (bilirubin \<=1.5 fold the upper limit of normal and liver enzymes \< 3 fold the upper limit of normal).
• Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors \>1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated).

You may not qualify if:

• Prior radiation to the chest
• Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure.
• Pregnant or breast-feeding females
• Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration
• Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma; Carcinoma, Squamous Cell

Interventions

Docetaxel; Fluorouracil; Radiotherapy; Esophagectomy; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

There are no statistical data analysis results available due to the protocol terminated early due to low rate of accrual, changes in treatment paradigm (patients are going for local excision for T1b esophageal cancer). We incorporated the analysis of those patient to the paper of a retrospective cohort, since the 4 patients themselves were not reportable.

Results Point of Contact

• Title: Steven H. Lin, Associate Professor, Radiation Oncology Department
• Organization: UT MD Anderson Cancer Center

shlin@mdanderson.org

(713) 563-8490

Study Officials

• Steven H. Lin, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: June 14, 2020
• Study Completion: June 14, 2020
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-04

Locations

US (1)