Esophageal CancerNCT05370144
A Study Involving Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma
A study testing Hypofractionated radiotherapy in people with Esophageal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Hypofractionated radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2023to 3 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
- Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
- Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm respectively.
- ECOG performance status ≤ 2
- Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
- Age ≥ 18 and ≤ 80.
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- Adequate hematological, renal, hepatic and pulmonary function as defined by:
- Hemoglobin > 100 g/L
- Platelet count > 100x109/L
- Absolute neutrophil count > 1.5x109/L
- Total bilirubin ≤ 1.5x the upper limit of institutional normal
- Creatinine ≤ 120 µmol/L
- FEV1 ≥ 1.5 L
- Patients capable of childbearing are using adequate contraception.
- Written and informed consent of patient.
Who cannot join
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of the cervix or a cured malignancy more than 5 years prior to enrollment
- Previous chemotherapy and radiotherapy
- New York heart Association Class III/IV and no history of active angina. Documented myocardial infarction within the 6 months preceding registration (pretreatment echocardiogram evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
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- Weight loss > 20% within 3 months of the date of screening
- Esophageal stent
- Pregnant or lactating patients; women of childbearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of childbearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.
- Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- Unable to complete surveys in English without aid of interpreter.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
About this study
Official title: Phase II Study of Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma
An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.
Read the detailed description
Patients with carcinoma of the esophagus or gastroesophageal junction who are suitable for curative intent trimodality therapy will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously weekly for 5 weeks. External beam RT in 5 fractions over 1 week will be delivered any time between week 3-5 of chemotherapy. Ideally patients should get radiotherapy during week 3 of chemotherapy but delivery during week 4-5 is permissible with documentation of the minor deviation. RT must start within 30 calendar days of signing the informed consent form. While restaging imaging is done as per institutional guidelines, ideally patients should get a PET/CT 6 weeks post chemoradiotherapy. Patient will then go for esophagectomy 6-12 weeks after the completion of chemoradiotherapy, but ideally at 6-8 weeks post chemoradiotherapy. Patients will be assessed for acute toxicity weekly during neoadjuvant therapy and then biweekly until esophagectomy. One month after surgery, patient will have a final clinical follow up with the radiation oncologist and review any post-operative complications.
- Conditions
- Esophageal Cancer
- Being tested
- Hypofractionated radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
Hypofractionated radiation 23 Gy in 5 fractions with a simultaneous integrated boost of 26 Gy in 5 fractions to the gross tumor volume (GTV) given concurrently over 1 week during week 3 of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated neoadjuvant concurrent chemoradiotherapy | Experimental | Drug: Carboplatin and Taxol (paclitaxel)
Patients will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously for 5 weeks on Days 1,8,15,22 and 29.
Radiation: Hypofractionated radiation Receives: Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy
Tumor regression grades and pathological complete response rates determined after one week of surgery
Measured: up to the Post-operative visit (60-90 days after surgery)
Secondary outcomes (5)
To determine the rates of acute toxicities
Safety will be determined by recording adverse events as per the CTCAE classification and grading system
Measured: up to the Post-operative visit (60-90 days after surgery)
To compare pathological response rates to changes in tumor FDG-PET uptake
Changes in tumor FDG-PET standard uptake value and total lesion glycolysis
Measured: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to changes in tumor dimensions
Changes in tumor dimensions on CT
Measured: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to dysphagia scores
Change in dysphagia score, measured at Screening/Baseline and at the Post-operative clinical follow-up
Measured: up to the Post-operative visit (60-90 days after surgery)
Correlate pre- and post-chemoradiation immune microenvironment composition with the above outcome variables (pathological response, dysphagia scores, changes in FDG-PET uptake and/or tumor dimensions on CT)
Translational correlation between immune infiltration of biopsy and resection specimens with pathological (regression grades and response rates), clinical (dysphagia scores) and imaging (FDG-PET uptake and/or tumor dimensions on CT) outcomes
Measured: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start8 Feb 2023
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370144
- Sponsor's protocol ID
- NACEA
- Status last verified
- Oct 2026
- First submitted
- 4 May 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05370144
- Acronym / sponsor ID
- NACEA
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2028 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.
Detailed description
Patients with carcinoma of the esophagus or gastroesophageal junction who are suitable for curative intent trimodality therapy will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously weekly for 5 weeks. External beam RT in 5 fractions over 1 week will be delivered any time between week 3-5 of chemotherapy. Ideally patients should get radiotherapy during week 3 of chemotherapy but delivery during week 4-5 is permissible with documentation of the minor deviation. RT must start within 30 calendar days of signing the informed consent form. While restaging imaging is done as per institutional guidelines, ideally patients should get a PET/CT 6 weeks post chemoradiotherapy. Patient will then go for esophagectomy 6-12 weeks after the completion of chemoradiotherapy, but ideally at 6-8 weeks post chemoradiotherapy. Patients will be assessed for acute toxicity weekly during neoadjuvant therapy and then biweekly until esophagectomy. One month after surgery, patient will have a final clinical follow up with the radiation oncologist and review any post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated neoadjuvant concurrent chemoradiotherapy | Experimental | Radiation: Hypofractionated radiotherapyDrug: Carboplatin and Taxol (paclitaxel) Patients will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously for 5 weeks on Days 1,8,15,22 and 29. Radiation: Hypofractionated radiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
- Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
- Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm respectively.
- ECOG performance status ≤ 2
- Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
Key exclusion criteria (11 listed)
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of the cervix or a cured malignancy more than 5 years prior to enrollment
- Previous chemotherapy and radiotherapy
- New York heart Association Class III/IV and no history of active angina. Documented myocardial infarction within the 6 months preceding registration (pretreatment echocardiogram evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapyHypofractionated radiation 23 Gy in 5 fractions with a simultaneous integrated boost of 26 Gy in 5 fractions to the gross tumor volume (GTV) given concurrently over 1 week during week 3 of chemotherapy. | Radiation | Hypofractionated neoadjuvant concurrent chemoradiotherapy |
Primary outcome
To determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy
Time frame: up to the Post-operative visit (60-90 days after surgery)
Tumor regression grades and pathological complete response rates determined after one week of surgery
5 secondary outcomes
To determine the rates of acute toxicities
Time frame: up to the Post-operative visit (60-90 days after surgery)
To compare pathological response rates to changes in tumor FDG-PET uptake
Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to changes in tumor dimensions
Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
To compare pathological response rates to dysphagia scores
Time frame: up to the Post-operative visit (60-90 days after surgery)
Correlate pre- and post-chemoradiation immune microenvironment composition with the above outcome variables (pathological response, dysphagia scores, changes in FDG-PET uptake and/or tumor dimensions on CT)
Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiotherapy in people with Esophageal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy (time frame: up to the Post-operative visit (60-90 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.