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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT03161522
First received: May 18, 2017
Last updated: May 18, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Malignant Neoplasms of Digestive Organs
Esophageal Cancer
Gastric Cancer
Drug: Chemotherapy
Radiation: Radiation
Procedure: Surgery
Behavioral: Symptom Questionnaires
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ]
    OS estimated by the method of Kaplan and Meier


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 5 years ]
    PFS estimated by the method of Kaplan and Meier

  • Quality of Life measured by the MDASI [ Time Frame: At follow up visits for 5 years ]
    Quality of life measured by the MDASI

  • Toxicity assessed by CTCAE v4 criteria [ Time Frame: At follow up visits for 5 years ]
    Toxicity assessed by CTCAE v4 criteria


Estimated Enrollment: 100
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maintenance Chemotherapy

Participants receive Maintenance chemotherapy after 6 cycles of induction chemotherapy.

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

Drug: Chemotherapy
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.
Behavioral: Symptom Questionnaires
Symptom questionnaire completed at baseline consultation and subsequently for every follow up after treatment.
Other Name: Surveys
Experimental: Local Consolidation Therapy (LCT)

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.

Drug: Chemotherapy
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.
Radiation: Radiation
Dose of radiation therapy at discretion of treating radiation oncologist.
Other Names:
  • XRT
  • External beam radiation therapy
  • EBRT
Procedure: Surgery
If eligible, surgery performed to all involved sites.
Behavioral: Symptom Questionnaires
Symptom questionnaire completed at baseline consultation and subsequently for every follow up after treatment.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03161522

Contacts
Contact: Quynh nhu Nguyen, MD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Quynh nhu Nguyen, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03161522     History of Changes
Other Study ID Numbers: 2016-0972
Study First Received: May 18, 2017
Last Updated: May 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of digestive organs
Esophageal Cancer
Gastric Cancer
Oligometastatic
Chemotherapy
Radiation therapy
Surgery
Questionnaires
Surveys

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 23, 2017