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Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers (GABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515941
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Brandon G. Smaglo, Baylor College of Medicine

Brief Summary:

This is an open-label, stratified, two arm design. All patients receive same initial standard preoperative chemotherapy and surgical resection. Patients will then be assigned to either standard postoperative chemotherapy if node negative at surgery or standard postoperative chemoradiation if node positive at surgery.

The primary objective of this study is to determine the feasibility of patients enrolling and receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status at surgery, following preoperative chemotherapy.

The secondary Objectives is to evaluate the rate of cancer recurrence in patients assigned to treatment based upon node status. To explore the potential correlation between changes in expression of a pre-specified panel of genes identified as relevant to gastrointestinal cancers in response to preoperative chemotherapy, using presence of nodal involvement at time of surgery as an indicator of response.


Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Drug: Oxaliplatin Drug: Capecitabine Drug: Leucovorin Drug: 5-fluorouracil Radiation: radiation Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study in Gastric Cancer of Assignment to Postoperative Chemoradiation or Chemotherapy Based Upon Surgical Lymph Node Assessment After Preoperative Chemotherapy, With Gene Assay as Correlate of Biologic Response
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : October 8, 2022
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Adjuvant Chemotherapy
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 mg/m2 by PO (BID) on 21 day-cycle, or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Drug: Oxaliplatin
130 mg/m2 by IV (Arm 1)

Drug: Capecitabine
625 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Drug: Leucovorin
400 mg/m2 by IV (Arm 1 & Arm 2)

Drug: 5-fluorouracil
400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Experimental: Arm 2: Adjuvant Chemoradiation
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Drug: Capecitabine
625 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)

Drug: Leucovorin
400 mg/m2 by IV (Arm 1 & Arm 2)

Drug: 5-fluorouracil
400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)

Radiation: radiation
45 Gy in 1.8 Gy/fraction




Primary Outcome Measures :
  1. Proportion of patients who complete the recommended therapy from each arm [ Time Frame: From date of assigned therapy up to 17 weeks ]
    The number of patients who complete the recommended therapy will be counted for each arm. The proportion is calculated when the last patient completes the therapy assigned.


Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: From the end of completion of assigned therapy until 36 months ]
    Return of disease



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have pathologically-proven adenocarcinoma of the stomach or gastroesophageal (GE)-junction, stage M0, as established by both imaging and surgical pathologic staging.

    Imaging: Clinical stage of M0 will be established by either CT (chest with contrast and abdomen/pelvis with and without contrast), or CT/PET (skull base to mid-thigh). This is standard post-surgery imaging.

    Surgery: Surgical pathologic staging must be M0.

  2. Must have completed 3 cycles of neo-adjuvant chemotherapy. Either CAPEOX or FOLFOX is allowed. Dose modifications are allowed, but all 3 cycles must have been completed.
  3. Must have undergone a surgical resection with definitive intent, either by open or laparoscopic resection of the primary gastric or GE junction cancer. Patients must have undergone a total gastrectomy, subtotal gastrectomy, or distal gastrectomy (depending on the location of primary gastric lesion) with at least a modified D2 lymphadenectomy.
  4. Must be deemed as a good candidate for adjuvant chemotherapy or chemoradiation (to start within 3 months of surgery), in the opinion of the treating investigator. Plan must be to start adjuvant therapy within 90 days of surgery; adjuvant treatment cannot begin more than 90 days after surgery.
  5. Must have diagnostic biopsy tissue (pre-neoadjuvant chemo) available for genetic testing.
  6. Must have surgical tissue (post-neoadjuvant chemo) available for genetic testing.
  7. Must be > 18 years of age.
  8. Must be able to provide informed consent.
  9. Must have adequate kidney, liver, and bone marrow function, within 28 days prior to registration, as follows:

    i. Hemoglobin ≥ 8.0 gm/dL

    ii. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3

    iii. Platelet count ≥ 75,000 /mm3

    iv. Calculated creatinine clearance of > 60 mL/min/m2, calculated as follows:

    For males = ((140 - age [years]) x (body weight [kg])) / ((72) x (serum creatinine [mg/dL])

    For females = 0.85 x male value

    v.Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

    vi.AST (SGOT) and ALT (SGPT) ≤ 3.0 times the ULN

  10. Must have life expectancy of greater than 3 months.
  11. Must have an ECOG performance status 0-2.
  12. Male or female patients of childbearing potential must be willing to use contraceptive precautions throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

  1. Other than the 3 cycles of neoadjuvant chemotherapy and surgery (mentioned above), must not have received other treatment for their gastric cancer.
  2. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Women of childbearing potential must have a negative serum pregnancy test as a part of eligibility, within 28 days of registration.
  3. Patients unwilling or unable to comply with the protocol, or provide informed consent.
  4. Patients with clinical evidence of metastatic disease.
  5. Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study and treatment plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515941


Contacts
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Contact: Brandon Smaglo, MD 713-798-3752 smaglo@bcm.edu
Contact: Brandon Smaglo, MD

Locations
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United States, Texas
Baylor Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Brandon Smaglo, MD    713-798-3752    smaglo@bcm.edu   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Brandon Smaglo, MD       smaglo@bcm.edu   
Sub-Investigator: Benjamin Musher, MD         
Sub-Investigator: Yvonne Sada, MD         
Sub-Investigator: Courtney Miller-Chism, MD         
Sub-Investigator: Henry Mok, MD         
Sub-Investigator: Eugene Choi, MD         
Baylor St. Lukes Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Brandon Smaglo    713-798-3752    smaglo@bcm.edu   
Harris Health System- Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Brandon Smaglo, MD    713-798-3752    smaglo@bcm.edu   
Sponsors and Collaborators
Brandon G. Smaglo
Investigators
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Principal Investigator: Brandon Smaglo Baylor College of Medicine

Publications:

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Responsible Party: Brandon G. Smaglo, Assistant Professor of Medicine - Hematology and Oncology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03515941    
Other Study ID Numbers: H-40682
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brandon G. Smaglo, Baylor College of Medicine:
chemotherapy
chemoradiation
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs