Phase 3 Oesophageal Cancer Trial, Recruiting NCT03801876 Sponsor: NRG Oncology Condition: Oesophageal Cancer
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Phase 3 Oesophageal Cancer Trial, Recruiting

NCT03801876
Recruiting Phase 3

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 through a tissue biopsy with a specific type of esophageal or gastroesophageal junction cancer (adenocarcinoma or squamous cell carcinoma) in the chest area
  • People whose cancer has been staged as Stage I through Stage IVA (but not classified as T4b, meaning the tumour has not grown into certain nearby structures), based on scans and physical examination
  • People who have had a surgical consultation to assess whether surgery may be an option after completing chemotherapy with radiation
  • People who may have previously had a minor surgical procedure called endoscopic mucosal resection (EMR) and still meet the staging requirements above
  • People who received certain chemotherapy regimens (FOLFOX, CAPOX, D-FLOT, or FLOT) before starting the trial's treatment, as long as the last dose was given between 10 and 90 days before joining
  • People aged 18 or older
  • People who are reasonably well and able to carry out daily activities (as measured by a standard health performance scale scoring 0, 1, or 2)
  • People whose recent blood tests show their white blood cell counts, platelet counts, haemoglobin, kidney function, and liver function are within required ranges (tested within 30 days before joining)
  • Women who could become pregnant must have a negative pregnancy test within 14 days before joining
  • People (or their legal representative) who are willing and able to provide written informed consent before entering the study

Who may not be able to join:

  • People whose cancer is located in the upper part of the oesophagus, very close to the mouth (15–18 cm from the front teeth)
  • People whose cancer is classified as T4b, meaning it has grown into certain nearby organs or structures
  • People with clear evidence that the cancer has spread to distant parts of the body (metastatic disease)
  • People who have had another active cancer diagnosis within the past 2 years that could affect how their oesophageal cancer is treated
  • People who have previously received radiation therapy to the chest in a way that would overlap with the radiation fields planned for this trial
  • People with serious active health conditions at the time of joining, including: an active infection currently requiring intravenous (IV) antibiotics; uncontrolled heart failure, unstable chest pain (angina), or a heart rhythm problem that cannot be managed with medication or a device; or a heart attack within the past 3 months
  • People who are currently pregnant or breastfeeding
  • People who are HIV-positive with a low immune cell count (CD4 count below 200 cells per microlitre) — people who are HIV-positive may still be considered eligible if they are on effective HIV treatment and their CD4 count is at or above 200 cells per microlitre (HIV testing is not required to apply)
  • People for whom confirmation of payment coverage (such as insurance) cannot be obtained for either possible radiation treatment option in the 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 27 July 2026
Phase 3: approximately ~65% 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.

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
NRG Oncology
Registry
ClinicalTrials.gov
Start date
26 June 2019
Est. completion
21 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall survival (OS); Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment

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: 27 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