Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

NCT00525785 | Completed Phase 2 Results

• 2 other identifiers: 2003-0769NCI-2010-00749
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.

Conditions

Stomach Cancer; Gastric Cancer

Keywords

Stomach Cancer; Gastric Cancer; Adenocarcinoma of the Stomach; Gastroesophageal Junction; Esophageal; Gastric; 5-Fluorouracil; 5-FU; Adrucil; Efudex; Folinic Acid; Oxaliplatin; Eloxatin; Chemoradiotherapy; Radiation; Radiotherapy; XRT

Outcome Measures

Primary Outcomes (1)

• Complete Pathologic Response Rate

  The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.

  Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment

Study Arms (1)

5-Fluorouracil + Folinic Acid + Oxaliplatin

EXPERIMENTAL

PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy

Drug: 5-Fluorouracil; Drug: Folinic Acid; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Surgery

Interventions

5-Fluorouracil DRUG

2.2 Gm/m\^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump.

Also known as: 5-FU, Adrucil, Efudex

5-Fluorouracil + Folinic Acid + Oxaliplatin

Folinic Acid DRUG

200 mg/m\^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.

5-Fluorouracil + Folinic Acid + Oxaliplatin

Oxaliplatin DRUG

100 mg/m\^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 45 mg/m\^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week).

Also known as: Eloxatin

5-Fluorouracil + Folinic Acid + Oxaliplatin

Radiotherapy RADIATION

45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.

Also known as: XRT

5-Fluorouracil + Folinic Acid + Oxaliplatin

Surgery PROCEDURE

4-6 weeks after completion of chemoradiotherapy, restaged \& surgical resection of the primary tumor and lymph nodes attempted.

5-Fluorouracil + Folinic Acid + Oxaliplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with potentially resectable adenocarcinoma of the stomach with histologic proof of adenocarcinoma, clinically staged T2-3, any N, M0 or T1N1M0 Gastric carcinoma may involve the gastroesophageal junction, however, the bulk of the tumor must be in the stomach (defined by radiographs, endoscopy, or endoscopic ultrasonography).
• No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy.
• Patients must have a performance status of \< 2 Zubrod scale.
• Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \>1,500/µL, and platelet count of \> 100,000/µL), adequate liver function (bilirubin \<= 1.5 mg/dl), and adequate renal function (creatinine \<= 1.5 mg/dl).
• Pretreatment evaluations must be done per the guidelines in Section 8.0.
• A feeding jejunostomy must be inserted in all patients.
• Patient must sign an informed consent prior to study entry.
• Patient must be chronologic \<= 75.

You may not qualify if:

• Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography.
• Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed by laparoscopy.
• Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes.
• Evidence of metastatic disease to distant organs (biopsy is suggested for questionable findings).
• Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.
• Patients with diabetic neuropathy.
• Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
• Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin).
• Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi-Synthelabo: collaborator

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

Stomach Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Dr. Jaffer Ajani, MD / Professor, GI Medical Oncology
• Organization: The University of Texas (UT) MD Anderson Cancer Center

jajani@mdanderson.org

713-792-2828

Study Officials

• Jaffer Ajani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: January 1, 2004
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Locations

US (1)