Phase 2 Oesophageal Cancer Trial, Recruiting NCT04656041 Sponsor: Massachusetts General Hospital Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT04656041
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:

  • People who have been diagnosed with cancer of the gastroesophageal junction (where the stomach meets the food pipe) or esophagogastric cancer, confirmed by a laboratory test of tissue or cells from a specific network of institutions, and the cancer must be at a certain stage of local spread (T3/T4 or involving nearby lymph nodes over 1 cm or showing up on a specific type of scan).
  • People aged 18 or older — there is no upper age limit.
  • People who are generally able to carry out daily activities with no or minimal limitations, as assessed by a doctor using a standard scale (ECOG score of 0 or 1).
  • People with a life expectancy of more than 3 months.
  • People whose blood counts, liver function, and kidney function fall within acceptable ranges as measured by blood tests (confirm with trial site for exact values).
  • People who are willing and able to use effective contraception (such as hormonal or barrier methods, or abstinence) throughout the study and for 30 days after the last dose of study treatment — this applies to both women who could become pregnant and to men.
  • Women who could become pregnant must have a negative pregnancy test (urine or blood) before joining.
  • People who are able to understand the study information and are willing to sign a consent form.

Who may not be able to join:

  • People whose cancer has spread to distant parts of the body (metastatic disease), as shown on scans done within six weeks of joining (some distant lymph node involvement may be allowed if it falls within the treatment area — confirm with trial site).
  • People who have already received chemotherapy, targeted therapy, biological therapy, or radiation treatment for this particular cancer.
  • People who have been treated for another serious (invasive) cancer within the last five years, where the chance of that cancer coming back is greater than 5% — though certain non-invasive skin cancers and early-stage surface cancers are generally acceptable.
  • People who have taken part in another clinical trial and received an experimental treatment within the 4 weeks before starting this study.
  • People with serious heart or lung conditions that are not well controlled, or who have had a heart attack within the past 12 months, or who currently have an active infection with fever.
  • People with a history of uncontrolled seizures, significant nervous system disorders, or psychiatric conditions that a doctor judges could affect their ability to consent or follow the study requirements.
  • People who are currently pregnant or breastfeeding, as the treatments used in this trial carry known risks to unborn babies and potential risks to nursing infants.
  • People who have had major surgery (not including keyhole/laparoscopic procedures) within 4 weeks before starting the study and have not fully recovered.
  • People currently taking the medication cimetidine (a type of stomach acid medicine), as it can interfere with one of the study drugs — a different acid-reducing medicine may be substituted before joining (confirm with trial site).
  • People with an existing blood-clotting disorder that is not under control.
  • People who have previously received a type of chemotherapy drug called a fluoropyrimidine as a systemic (whole-body) treatment, unless it was given as a follow-up (adjuvant) treatment and finished at least six months ago — previous use of fluoropyrimidine creams or skin treatments is generally acceptable.
  • People with a known allergy or serious reaction to the drug 5-fluorouracil, or who are known to have a specific enzyme deficiency (DPD deficiency) that affects how this drug is processed by the body.
  • People with a history of allergic reactions to drugs chemically similar to 5-fluorouracil, irinotecan, or oxaliplatin — three of the drugs used in this trial.

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 28 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: Jennifer Wo, MD, Massachusetts General Hospital

Phone: (617) 726-6050

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
29 June 2021
Est. completion
30 April 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pathologic Complete Response Rate

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: 28 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