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Trial record 1 of 1 for:    A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy followed by Chemotherapy for Resectable Gastric Adenocarcinoma
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Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT04523818
Recruitment Status : Active, not recruiting
First Posted : August 24, 2020
Last Update Posted : January 25, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as 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 sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.

Condition or disease Intervention/treatment Phase
Clinical Stage I Gastric Cancer AJCC v8 Clinical Stage IIA Gastric Cancer AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage IVA Gastric Cancer AJCC v8 Gastric Adenocarcinoma Pathologic Stage IB Gastric Cancer AJCC v8 Pathologic Stage II Gastric Cancer AJCC v8 Pathologic Stage IIA Gastric Cancer AJCC v8 Pathologic Stage IIB Gastric Cancer AJCC v8 Pathologic Stage III Gastric Cancer AJCC v8 Pathologic Stage IIIA Gastric Cancer AJCC v8 Pathologic Stage IIIB Gastric Cancer AJCC v8 Pathologic Stage IIIC Gastric Cancer AJCC v8 Postneoadjuvant Therapy Stage I Gastric Cancer AJCC v8 Postneoadjuvant Therapy Stage II Gastric Cancer AJCC v8 Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8 Drug: Capecitabine Drug: Fluorouracil Radiation: Radiation Therapy Procedure: Therapeutic Surgical Procedure Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma.

SECONDARY OBJECTIVES:

I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT.

II. To assess the rate of perioperative complications after gastrectomy in patients treated with preoperative short-course CXRT.

III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT.

OUTLINE:

Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.

After the completion of study treatment, patients are followed up every 6 months for 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (CXRT, chemotherapy, surgery)
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine PO BID or fluorouracil IV continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
Drug: Capecitabine
Given PO
Other Names:
  • Ro 09-1978/000
  • Xeloda

Drug: Fluorouracil
Given IV
Other Names:
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Procedure: Therapeutic Surgical Procedure
Undergo standard of care surgery




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 4 weeks following last chemotherapy ]
    Characterized by the incidence and severity of treatment-related adverse events. Grade 3 or higher toxicity classified as attributable to chemotherapy and radiation treatment (CXRT), during the 14 days of treatment administration or within 14 days of completion of CXRT (i.e., a total of 28 days), based on multidisciplinary review, will be used for the purpose of toxicity monitoring. Differences between grades vary and are detailed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. In general, Grade 3 toxicity refers to any event that requires hospitalization with intervention (i.e., intravenous [IV] hydration, symptomatic control, transfusion, procedure, etc.).


Secondary Outcome Measures :
  1. Rate of pathologic complete response in patients treated with resection [ Time Frame: Up to 5 years ]
    Will be estimated, along with exact 95% confidence intervals.

  2. Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy [ Time Frame: Up to 5 years ]
    Will be estimated, along with exact 95% confidence intervals.

  3. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Will be evaluated using the Kaplan-Meier method. Median OS and the 95% confidence interval will be reported.



Information from the National Library of Medicine

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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:

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patients with a biopsy-confirmed diagnosis of adenocarcinoma of the stomach
  • No evidence of distant metastatic disease based on standard of care preoperative imaging evaluation
  • Evidence of T2 stage or greater primary tumor, or any T stage with node positive disease based on endoscopic ultrasound or standard of care imaging
  • Leukocytes >= 3,000/ul
  • Absolute neutrophil count >= 1,500/ul
  • Platelets >= 60,000/UI
  • Glomerular filtration rate >= 60 mL/min/1.73 m^2. The estimated glomerular filtration rate (eGFR) is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The eGFR declines with age. eGFR < 60 mL/min/1.73 m2 is considered as "decreased". This equation should only be used for patients 18 and older. According to the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) classification and 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline, the stage of CKD should be categorized based on estimated GFR

Exclusion Criteria:

  • Presence of metastatic disease on staging with standard of care imaging, with or without diagnostic laparoscopy. Subjects not able to undergo staging laparoscopy due to previous surgery will not be excluded from this trial, and the determination of absence of metastatic disease will be decided solely on imaging consistent with our current standard of care
  • Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
  • Infections such as pneumonia or wound infections that would preclude protocol therapy
  • Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, barrier methods, or abstinence. Contraception for males consists of barrier methods or abstinence
  • Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
  • Subjects deemed unable to comply with study and/or follow-up procedures
  • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
  • Prior radiotherapy to the same field
  • Comorbid conditions (examples - collagen vascular diseases, certain genetic conditions that predispose to secondary malignancies) that are prohibitive to preoperative therapy, or contraindications to radiotherapy

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): NCT04523818


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brian D Badgwell M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04523818    
Other Study ID Numbers: 2020-0481
NCI-2020-05810 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0481 ( Other Identifier: M D Anderson Cancer Center )
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs