Phase 2 Oesophageal Cancer Trial, Recruiting NCT03161522 Sponsor: M.D. Anderson Cancer Center Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT03161522
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with esophageal or gastric (stomach) cancer of a specific type called adenocarcinoma, confirmed by a biopsy or tissue sample.
  • You have had specific scans (including a scope of the digestive tract and a PET/CT scan) to determine the stage of your cancer.
  • You have three or fewer areas in your body where the cancer has spread (metastases), either at diagnosis or after an initial round of chemotherapy has reduced the number of spread sites to three or fewer.
  • Each type of spread counts separately: spread to lymph nodes in distant areas counts as one site total; spread to bones counts as one site; spread to the brain, each individual spot counts as one site.
  • You are physically well enough to carry out basic daily activities (rated on a standard scale from 0–2) and are expected to live at least 6 months or more.
  • You are between 18 and 80 years old and are able to give written consent to participate.
  • If you are a woman who could become pregnant, you must take a pregnancy test at enrollment and agree to use reliable contraception during the study and for six months after treatment ends.

Who may not be able to join:

  • You have already received chemotherapy or radiation therapy for your esophageal or gastric cancer diagnosis.
  • You have had previous radiation to the same body area for a different cancer.
  • You have an abnormal opening or connection between organs (called a fistula), confirmed by imaging or a scope procedure.
  • Your life expectancy is less than 6 months, or your general health and ability to function is severely limited (confirm with trial site).
  • You are pregnant, confirmed by a blood test.
  • You have a history of uncontrolled chest pain (angina), heart failure, or a heart attack within the last 6 months.
  • You are currently breastfeeding.
  • You are in a poor nutritional state (confirm with trial site on what this means for you).
  • Your bone marrow is not working well enough to produce healthy blood cells.
  • You have a serious active infection.
  • You have a known allergy or sensitivity to the chemotherapy drug 5-fluorouracil (5-FU).
  • You are known or suspected to have a condition called dihydropyrimidine dehydrogenase (DPD) deficiency, which makes it harder for your body to process certain chemotherapy drugs safely (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Quynh-Nhu Nguyen, M.D. Anderson Cancer Center

Phone: 713-563-2300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
19 February 2018
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov