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

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



Sponsors


Source

M.D. Anderson Cancer Center

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No

Is Us Export

No


Brief Summary

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.

Detailed Description

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.

Overall Status

Not yet recruiting

Start Date

2017-07-01

Completion Date

2023-07-01

Primary Completion Date

2023-07-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Overall Survival (OS)
5 years

Secondary Outcome

Measure

Time Frame

Progression-Free Survival (PFS)
5 years
Quality of Life measured by the MDASI
At follow up visits for 5 years
Toxicity assessed by CTCAE v4 criteria
At follow up visits for 5 years

Enrollment

100

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

Chemotherapy may include the following alone or in combination with each other: Cisplatin, 5-fluorouracil (5-FU), Mitomycin C, Vindesine, or Paclitaxel at discretion of physician.

Arm Group Label

Maintenance Chemotherapy

Local Consolidation Therapy (LCT)



Intervention Type

Radiation

Intervention Name


Description

Dose of radiation therapy at discretion of treating radiation oncologist.

Arm Group Label

Local Consolidation Therapy (LCT)

Other Name

XRT

External beam radiation therapy

EBRT



Intervention Type

Procedure

Intervention Name


Description

If eligible, surgery performed to all involved sites.

Arm Group Label

Local Consolidation Therapy (LCT)


Intervention Type

Behavioral

Intervention Name


Description

Symptom questionnaire completed at baseline consultation and subsequently for every follow up after treatment.

Arm Group Label

Maintenance Chemotherapy

Local Consolidation Therapy (LCT)


Other Name

Surveys



Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Quynh nhu Nguyen, MD
Principal Investigator
M.D. Anderson Cancer Center

Overall Contact

Last Name

Quynh nhu Nguyen, MD

Phone

713-563-2300

Email



Location

Facility

Status

Contact

University of Texas MD Anderson Cancer Center
Houston Texas 77030 United States
Not yet recruiting
Last Name: Clinical Research Operations
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Maintenance Chemotherapy

Arm Group Type

Experimental

Description

Participants receive Maintenance chemotherapy after 6 cycles of induction chemotherapy.
Symptom questionnaire completed at baseline consultation and subsequently for every follow up after treatment.


Arm Group Label

Local Consolidation Therapy (LCT)

Arm Group Type

Experimental

Description

LCT may include chemotherapy with radiation and surgery after 6 cycles of induction chemotherapy.
Symptom questionnaire completed at baseline consultation and subsequently for every follow up after treatment.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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