NCT00086996|CompletedPhase 2ResultsDMC

S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000371963U10CA032102S0356

Study Type

interventional

Target

Locations

1 country

Sites

143

Timeline

RegisteredJul 2004

StartedSep 2004

CompletionAug 2011

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach

1 country

143 active sites

Status

completed

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

6.9 years study duration

First Submitted

Initial submission to the registry

July 8, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed

2 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed

8 months until next milestone

Results Posted

Study results publicly available

April 3, 2012

Completed

Last Updated

October 11, 2013

Status Verified

September 1, 2013

Enrollment Period

4.9 years

First QC Date

July 8, 2004

Results QC Date

March 5, 2012

Last Update Submit

September 4, 2013

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagusstage II esophageal cancerstage III esophageal cancer

Outcome Measures

Primary Outcomes (1)

Pathological Complete Response
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
10-16 weeks after beginning study treatment

Secondary Outcomes (3)

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Up to 3 years
Overall Survival
0-5 years
Progression-free Survival
0-3 years

Study Arms (1)

Chemo Plus RT, Surgery, Chemo

EXPERIMENTAL

neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin

Drug: fluorouracilDrug: oxaliplatinProcedure: conventional surgeryRadiation: radiation therapy

Interventions

fluorouracilDRUG

Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.

Also known as: 5-FU

Chemo Plus RT, Surgery, Chemo

oxaliplatinDRUG

Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.

Also known as: eloxatin

Chemo Plus RT, Surgery, Chemo

conventional surgeryPROCEDURE

The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.

Chemo Plus RT, Surgery, Chemo

radiation therapyRADIATION

Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.

Chemo Plus RT, Surgery, Chemo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction * No recurrent disease * Primary esophageal tumor at least 20 cm below the incisors (if \< 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative) * Esophageal disease confined to esophagus and peri-esophageal soft tissue * Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia * Clinical stage II or III disease by CT scan or MRI * If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage * Positron-emission tomography scan is required to confirm stage * Measurable or non-measurable disease by x-ray, scanning, or physical examination * No celiac axis nodes ≥ 1.5 cm * Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed * Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * White blood cell (WBC) count ≥ 3,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL (transfusion allowed) Hepatic * Albumin ≥ 3 g/dL * Bilirubin normal Renal * Creatinine ≤ 1.5 times upper limit of normal Cardiovascular * No myocardial infarction or cerebrovascular event within the past 6 months Pulmonary * No active pneumonia or inflammatory lung infiltrate Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy ≥ grade 2 * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for esophageal cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for esophageal cancer * No concurrent intensity-modulated radiotherapy Surgery * No prior surgical resection or attempted surgical resection of esophageal cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (143)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Highlands Oncology Group - Springdale

Bentonville, Arkansas, 72712, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus