Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and GEJ
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Cancer Gastric Cancer |
Drug: 5-Fluorouracil Drug: Folinic Acid Drug: Oxaliplatin Radiation: Radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction |
- Complete Pathologic Response Rate [ Time Frame: 4-6 weeks after completion of chemoradiotherapy ] [ Designated as safety issue: No ]
The complete pathologic response (path CR) rate after the 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.
Follow up 3, 6, 9, and 12 months after surgery and every 6 months until Year 3, then once a year til Year 5.
| Estimated Enrollment: | 58 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-Fluorouracil + Folinic Acid + Oxaliplatin
5-Fluorouracil 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. Folinic Acid 200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43. Oxaliplatin 100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 45 mg/m2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week). Radiotherapy 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. |
Drug: 5-Fluorouracil
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. Other Names:
Drug: Folinic Acid
200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.
Drug: Oxaliplatin
100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43. Chemoradiotherapy: 45 mg/m2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week). Other Name: Eloxatin
Radiation: Radiotherapy
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.
Other Name: XRT
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jaffer Ajani, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525785 History of Changes |
| Other Study ID Numbers: | 2003-0769 |
| Study First Received: | September 4, 2007 |
| Last Updated: | December 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil |
Oxaliplatin Leucovorin Folic Acid Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on May 23, 2013