Chemotherapy with or without Radiation Therapy in Treating Participants with Gastric Cancer after Surgical Analysis of Lymph Nodes

Status: Active

Description

This early phase I pilot trial studies how well chemotherapy with or without radiation therapy work in treating participants with gastric cancer who have undergone surgical analysis of the lymph nodes. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. It is not yet known whether giving chemotherapy and radiation will work better in treating participants with gastric cancer.

Eligibility Criteria

Inclusion Criteria

  • 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 computed tomography (CT) (chest with contrast and abdomen/pelvis with and without contrast), or CT/positron emission tomography (PET) (skull base to mid-thigh). This is standard post-surgery imaging. *Surgery: Surgical pathologic staging must be M0.
  • Must have completed 3 cycles of neo-adjuvant chemotherapy. Either capecitabine-oxaliplatin (CAPEOX) or leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) is allowed. Dose modifications are allowed, but all 3 cycles must have been completed.
  • 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.
  • 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.
  • Must have diagnostic biopsy tissue (pre-neoadjuvant chemo) available for genetic testing.
  • Must have surgical tissue (post-neoadjuvant chemo) available for genetic testing.
  • Must be able to provide informed consent.
  • Hemoglobin >= 8.0 gm/dL within 28 days prior to registration.
  • Absolute neutrophil count (ANC) >= 1500 cells/mm^3 within 28 days prior to registration.
  • Platelet count >= 75,000 /mm^3 within 28 days prior to registration.
  • Calculated creatinine clearance of > 60 mL/min/m^2, within 28 days prior to registration.
  • Total bilirubin =< 1.5 times upper limit of normal (ULN) within 28 days prior to registration.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 times the ULN within 28 days prior to registration.
  • Must have life expectancy of greater than 3 months.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • 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

  • Other than the 3 cycles of neoadjuvant chemotherapy and surgery (mentioned above), must not have received other treatment for their gastric cancer.
  • 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.
  • Patients unwilling or unable to comply with the protocol, or provide informed consent.
  • Patients with clinical evidence of metastatic disease.
  • Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study and treatment plan.

Locations & Contacts

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Brandon G. Smaglo
Phone: 713-798-3752
Email: smaglo@bcm.edu
Baylor Saint Luke's Medical Center
Status: Active
Contact: Brandon G. Smaglo
Phone: 713-798-3752
Email: smaglo@bcm.edu
Ben Taub General Hospital
Status: Active
Contact: Brandon G. Smaglo
Phone: 713-798-3752
Email: smaglo@bcm.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of patients enrolling and receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status at surgery, following preoperative chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the rate of cancer recurrence in patients assigned to treatment based upon node status.

II. 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.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants with lymph node negative may receive oxaliplatin intravenously (IV) on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-5, 8-12, and 15-19. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients may alternately receive oxaliplatin IV on day 1, leucovorin calcium IV on day 1, fluorouracil IV bolus on day 1, and fluorouracil continuous IV infusion on days 1-3 over 46 hours. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Participants with lymph node positive receive capecitabine PO BID on days 1-14 or leucovorin calcium IV over 60 minutes, fluorouracil IV bolus on day 1, and fluorouracil over 46 hours on days 1-3. Treatment continues for 14 or 28 days in the absence of disease progression or unacceptable toxicity. Participants then undergo radiation therapy 5 days a week and receive capecitabine PO BID or fluorouracil IV on the same days as radiation therapy for 5 weeks. Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 28 days for 2 courses absence in the absence of disease progression or unacceptable toxicity. Participants may alternately receive leucovorin calcium IV over 60 minutes, fluorouracil IV bolus on day 1, and fluorouracil over 46 hours on days 1-3. Treatment repeats every 14 days for 2 courses absence in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 3 months for 36 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center

Principal Investigator
Brandon G. Smaglo

Trial IDs

Primary ID GABLE
Secondary IDs NCI-2018-00934
Clinicaltrials.gov ID NCT03515941