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Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

Primary Purpose

Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage IIA Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Fluorouracil
Radiation Therapy
Therapeutic Surgical Procedure
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage I Gastric Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (CXRT, chemotherapy, surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events
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

Rate of pathologic complete response in patients treated with resection
Will be estimated, along with exact 95% confidence intervals.
Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy
Will be estimated, along with exact 95% confidence intervals.
Overall survival (OS)
Will be evaluated using the Kaplan-Meier method. Median OS and the 95% confidence interval will be reported.

Full Information

First Posted
August 18, 2020
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04523818
Brief Title
Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma
Official Title
A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (CXRT, chemotherapy, surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Ro 09-1978/000, Xeloda
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Surgical Procedure
Intervention Description
Undergo standard of care surgery
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
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.).
Time Frame
Up to 4 weeks following last chemotherapy
Secondary Outcome Measure Information:
Title
Rate of pathologic complete response in patients treated with resection
Description
Will be estimated, along with exact 95% confidence intervals.
Time Frame
Up to 5 years
Title
Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy
Description
Will be estimated, along with exact 95% confidence intervals.
Time Frame
Up to 5 years
Title
Overall survival (OS)
Description
Will be evaluated using the Kaplan-Meier method. Median OS and the 95% confidence interval will be reported.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Badgwell
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

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