Study on Chemotherapy With or Without Radiation or Surgery for Treating Esophageal or Gastric Cancer That Has Spread to Less Than 3 Places

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03161522

Provider View

This clinical trial is exploring whether adding radiation or surgery to chemotherapy can better treat esophageal or gastric cancer that has spread to fewer than three areas in the body. The study aims to see if this combination can improve survival compared to chemotherapy alone.

Patient Parameters

Program Overview

This study is investigating how well chemotherapy, with or without radiation or surgery, works in treating esophageal or gastric cancer that has spread to less than three places in the body, known as oligometastatic cancer. Chemotherapy drugs like fluorouracil and capecitabine help stop cancer cells from growing and spreading. Radiation uses high-energy rays to kill cancer cells, and surgery can remove tumors. The study aims to find out if combining these treatments is more effective than chemotherapy alone.

Description

The study has two main goals:

Primary Objective:

  • To see if patients with esophageal or gastric cancer that has spread to a few places live longer when they receive early local therapy, which includes chemotherapy with radiation and possibly surgery, compared to chemotherapy alone.

Secondary Objectives:

  • To compare how long patients live without the cancer getting worse and overall survival between the two treatment groups.
  • To report how well the cancer is controlled locally and in nearby areas.
  • To report how long it takes for cancer to spread to new areas.
  • To report any side effects.

Study Outline: Participants will first receive chemotherapy for 6 to 8 cycles unless the cancer worsens or side effects are too severe. Then, they will be randomly assigned to one of two groups:

Group I (Maintenance Chemotherapy):

  • Participants will continue receiving chemotherapy drugs fluorouracil and capecitabine as long as the cancer does not worsen or side effects are manageable.

Group II (Local Therapy):

  • Participants will receive the same chemotherapy drugs and also undergo radiation therapy. Surgery may be performed on remaining cancer sites if deemed necessary by the doctor.

After completing the study treatment, participants will have follow-up visits at 4-8 weeks, then every 2-3 months, every 3-6 months for up to 3 years, and then every 6-12 months thereafter.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with esophageal or gastric cancer of adenocarcinoma type.
  • Cancer has spread to three or fewer places in the body.
  • Must have a life expectancy of at least 6 months and be in relatively good health (ECOG score of 0-2).
  • Aged between 18 and 80 years old.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during the study and for six months after treatment ends.

Exclusion Criteria

  • Have received chemotherapy or radiation for esophageal or gastric cancer before.
  • Have a fistula (abnormal connection between organs) confirmed by imaging.
  • Have a life expectancy of less than 6 months or poor health (ECOG score greater than 3).
  • Pregnant women or nursing mothers.
  • Have uncontrolled heart conditions or recent heart attack.
  • Have a tumor with Microsatellite Instability High (MSI-H) status.
  • Have poor nutrition, severe bone marrow issues, serious infections, or allergies to 5-fluorouracil.
  • Suspected to have a deficiency in breaking down certain chemotherapy drugs.

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