Chemoradiation +/- Surgery Versus Systemic Therapy for Esophageal or Gastric Cancer With Oligometastases



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2018
Start Date:February 19, 2018
End Date:February 2025
Contact:Quynh nhu Nguyen, MD
Email:CR_Study_Registration@mdanderson.org
Phone:713-563-2300

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

The goal of this clinical research study is to learn if adding additional chemotherapy and
radiation, either with or without surgery, can help to control esophageal or gastric cancer
with oligometastases in patients whose disease did not get worse after receiving at least 6
cycles of chemotherapy as part of their standard care.

Oligometastases means there are less than 3 places in the body where the disease has spread.

If participant agrees to take part in this study, participant will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one know if one group
is better, the same, or worse than the other. °If participant is assigned to Group 1,
participant will receive maintenance chemotherapy.

Maintenance therapy is given after participant has already received chemotherapy and is meant
to continue to prevent the return of the disease.

°If participant is assigned to Group 2, participant will receive local therapy, which may
include chemotherapy with radiation and surgery (if participant is eligible to have it).

Both participant and the study doctor will know to which group participant has been
randomized to.

The study doctor will tell participant which chemotherapy participant is receiving, when
participant will receive it, and its risks. This chemotherapy may include the following alone
or in combination with each other: cisplatin, 5-fluorouracil (5-FU), mitomycin C, vindesine,
or paclitaxel.

If participant is in Group 2 and participant is eligible, participant may receive radiation
therapy or surgery. These therapies will be provided as part of participant's standard care
and participant will receive separate consent forms for these procedures.

Participant will not have any clinic visits that are specific to this study. All clinic
visits will be scheduled as part of participant's routine care and would take place even if
participant was not taking part in this study.

Length of Participation:

Participant may receive treatment for as long as the doctor thinks it is in participant's
best interest. If the disease appears to get worse, participant may receive additional
treatment as part of participant's standard care (called second-line therapy). The study
doctor will discuss this with participant. Participant will no longer be able to receive
treatment if the disease gets worse, if intolerable side effects occur, or if participant is
unable to follow study directions.

Participation on this study will continue until the study ends.

Follow-Up:

As soon as participant finishes therapy, then about 4-8 weeks after that, and then every 3-6
months for up to 3 years after treatment with chemotherapy or radiation therapy:

- Participant will complete a questionnaire about participant's symptoms. This should take
about 10 minutes to complete.

- Participant will have imaging scans (such as an MRI, CT, PET-CT, FDG-PET, and so on) to
check the status of the disease. The doctor will tell participant which scan(s)
participant will have.

If participant has surgery as part of participant's standard care, participant will have the
above follow-up visit about 2-3 months after surgery and then every 3-6 months for up to 3
years.

After 3 years, participant will then have the above follow-up visit every 6-12 months until
the study ends or until follow-up visits are no longer needed for routine care.

This is an investigational study. The chemotherapy and radiation therapy used in this study
is FDA-approved and commercially available for the type of cancer you have. It is considered
investigational to use chemotherapy, alone or in combination with radiation therapy and
surgery, to treat esophageal or gastric cancer with oligometastases.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric
cancer of adenocarcinoma histology

2. The patient is staged with EUS/EGD and PET/CT scan.

3. 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.

4. Patient ECOG of 0-2, with life expectancy of at least 6 months

5. Patients age >18 yrs old but <80 yrs old and signed informed consent

6. 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:

1. 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.

2. Patients with fistula documented radiographically or by EDG/EUS, EBUS.

3. Patients with life expectancy less than 6 months, ECOG >3

4. Female patients who are pregnant confirmed by bHCG lab test.

5. Patient has history of uncontrolled angina, congestive heart failure or recent MI
within 6 months.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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