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Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma, Oligometastasis, Stage IV Esophageal Adenocarcinoma AJCC v7

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Chemotherapy
Conventional Surgery
Fluorouracil
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology The patient is staged with EGD and PET/CT scan.
  • The patient has three or less observable metastatic lesions. Patients may have three or less observable metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization.

The patient has three or less observable metastatic lesions. Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion).

Osseous metastases or visceral metastases will each count as one metastatic site.

Each CNS metastases will count as one metastatic site.

Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation.

  • Patient ECOG of 0-2, with life expectancy of at least 6 months
  • Patients age >18 yrs old but <80 yrs old and signed informed consent
  • Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents.

Exclusion Criteria:

  • Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized.
  • Patients with fistula documented radiographically or by EDG/EUS, EBUS.
  • Patients with life expectancy less than 6 months, ECOG >3
  • Female patients who are pregnant confirmed by bHCG lab test.
  • Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
  • Patients established to have a tumor with Microsatellite Instability High (MSIH) status.
  • Nursing females
  • Patients in poor nutritional state

Patients with:

  • Severely depressed bone marrow function
  • Potentially serious infections
  • Known hypersensitivity to 5-fluorouracil
  • Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (maintenance chemotherapy)

Group II (local therapy)

Arm Description

Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.

Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.

Outcomes

Primary Outcome Measures

Overall survival (OS)
OS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.

Secondary Outcome Measures

Local progression-free survival (PFS)
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Distant PFS
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Incidence of adverse events
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time to local or regional disease recurrence
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.

Full Information

First Posted
May 18, 2017
Last Updated
September 22, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03161522
Brief Title
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Official Title
A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (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 II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil and capecitabine, 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 x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether esophageal or gastric patients with oligometastatic cancer without disease progression after first line chemotherapy therapy will demonstrate improved overall survival (OS) with early local therapy (concurrent chemotherapy/radiation and surgery). SECONDARY OBJECTIVES: I. Assess the relationships between progression-free survival and overall survival between both treatment arms. II. Report local control, loco-regional control. III. Report time to progression of distant metastases. IV. Report toxicity. OUTLINE: Participants receive induction chemotherapy for a minimum of 6 cycles and a maximum of 8 cycles in the absence of disease progression or unacceptable toxicity. Participants are then randomized to 1 of 2 groups. GROUP I (MAINTENANCE CHEMOTHERAPY): Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. GROUP II (LOCAL THERAPY): Participants receive fluorouracil and capecitabine and undergo radiation therapy (RT) per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician. After completion of study treatment, participants are followed up at 4-8 weeks, 2-3 months, every 3-6 months for up to 3 years, and then every 6-12 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Oligometastasis, Stage IV Esophageal Adenocarcinoma AJCC v7, Stage IV Esophageal Cancer AJCC v7, Stage IV Gastric Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (maintenance chemotherapy)
Arm Type
Experimental
Arm Description
Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.
Arm Title
Group II (local therapy)
Arm Type
Experimental
Arm Description
Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Ro 09-1978/000, Xeloda
Intervention Description
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Intervention Description
Receive induction chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Intervention Description
Undergo surgery
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757
Intervention Description
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Intervention Description
Undergo RT
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Local progression-free survival (PFS)
Description
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Time Frame
Up to 6 years
Title
Distant PFS
Description
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Time Frame
Up to 6 years
Title
Incidence of adverse events
Description
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame
Up to 6 years
Title
Time to local or regional disease recurrence
Description
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Time Frame
Up to 6 years
Other Pre-specified Outcome Measures:
Title
Time to local disease recurrence
Description
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Time Frame
Up to 6 years
Title
Time to disease progression
Description
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology The patient is staged with EGD and PET/CT scan. The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT). The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion). Osseous metastases or visceral metastases will each count as one metastatic site. Each CNS metastases will count as one metastatic site. Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation. Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment. Patient ECOG of 0-2, with life expectancy of at least 6 months Patients age >18 yrs old but <80 yrs old and signed informed consent Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents. Exclusion Criteria: Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized. Patients with fistula documented radiographically or by EDG/EUS, EBUS. Patients with life expectancy less than 6 months, ECOG >3 Female patients who are pregnant confirmed by bHCG lab test. Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months. Patients established to have a tumor with Microsatellite Instability High (MSIH) status. Nursing females Patients in poor nutritional state Patients with: Severely depressed bone marrow function Potentially serious infections Known hypersensitivity to 5-fluorouracil Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quynh Nhu Nguyen, MD
Phone
713-563-2300
Email
qnnguyen@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen
Phone
713-563-2300
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer

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