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Gastric AdenocarcinomaPhase 2NCT03161522

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

A Phase 2 study testing Capecitabine, Chemotherapy and Conventional Surgery in people with Gastric Adenocarcinoma and Oligometastasis, run by M.D. Anderson Cancer Center at 1 site in United States.

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Trial 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). Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Capecitabine, Chemotherapy and Conventional Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
19 Feb 2018to 31 Dec 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • Nursing females
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Quynh Nhu Nguyen, MD contact

713-563-2300

qnnguyen@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Quynh-Nhu Nguyen, 713-563-2300

    Quynh-Nhu Nguyen

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Capecitabine, Chemotherapy, Conventional Surgery, Fluorouracil, Radiation Therapy
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Receive induction chemotherapy

  • Conventional SurgeryProcedure or surgery

    Undergo surgery

  • FluorouracilDrug

    Also called 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU

    Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    Undergo RT

Study groups in NCT03161522
Study groupRoleWhat they receive
Group I (maintenance chemotherapy)ExperimentalParticipants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Capecitabine; Drug: Chemotherapy; Drug: Fluorouracil
Group II (local therapy)ExperimentalParticipants 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.
Receives: Drug: Capecitabine; Drug: Chemotherapy; Procedure: Conventional Surgery; Drug: Fluorouracil; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 years

Secondary outcomes (4)

  1. 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.

    Measured: Up to 6 years

  2. 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.

    Measured: Up to 6 years

  3. Incidence of adverse events

    Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: Up to 6 years

  4. Time to local or regional disease recurrence

    To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start19 Feb 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161522
Sponsor's protocol ID
2016-0972
Other IDs
NCI-2018-01202, 2016-0972
Status last verified
Oct 2026
First submitted
18 May 2017
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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