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RecruitingNCT05370144Updated Nov 18, 2024

A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma

An interventional study of Hypofractionated radiotherapy in Esophageal Cancer, sponsored by AHS Cancer Control Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by AHS Cancer Control Alberta · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Esophageal Cancer

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 42 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
  2. Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
  3. 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.
  4. ECOG performance status ≤ 2
  5. Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
  6. Age ≥ 18 and ≤ 80.
  7. Adequate hematological, renal, hepatic and pulmonary function as defined by:

    1. Hemoglobin > 100 g/L
    2. Platelet count > 100x109/L
    3. Absolute neutrophil count > 1.5x109/L
    4. Total bilirubin ≤ 1.5x the upper limit of institutional normal
    5. Creatinine ≤ 120 µmol/L
    6. FEV1 ≥ 1.5 L
  8. Patients capable of childbearing are using adequate contraception.
  9. Written and informed consent of patient.

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Previous chemotherapy and radiotherapy
  3. 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
  4. Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
  5. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
  6. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  7. Weight loss > 20% within 3 months of the date of screening
  8. Esophageal stent
  9. 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.
  10. Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
  11. Unable to complete surveys in English without aid of interpreter.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Hypofractionated neoadjuvant concurrent chemoradiotherapy

    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

    Radiation: Hypofractionated radiotherapy

Interventions

  • RadiationHypofractionated radiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. To determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy

    Tumor regression grades and pathological complete response rates determined after one week of surgery

    Time frame: up to the Post-operative visit (60-90 days after surgery)

Secondary outcomes

  1. To determine the rates of acute toxicities

    Safety will be determined by recording adverse events as per the CTCAE classification and grading system

    Time frame: up to the Post-operative visit (60-90 days after surgery)

  2. To compare pathological response rates to changes in tumor FDG-PET uptake

    Changes in tumor FDG-PET standard uptake value and total lesion glycolysis

    Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).

  3. To compare pathological response rates to changes in tumor dimensions

    Changes in tumor dimensions on CT

    Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).

  4. To compare pathological response rates to dysphagia scores

    Change in dysphagia score, measured at Screening/Baseline and at the Post-operative clinical follow-up

    Time frame: up to the Post-operative visit (60-90 days after surgery)

  5. 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

    Time frame: At the time of the re-staging scan (6 weeks post chemoradiotherapy).

07

Study locations

1 of 1 sites recruiting
  • Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
    Calgary, Alberta, Canada
    • Sangjune Lee, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05370144
Lead sponsor
AHS Cancer Control Alberta
Responsible party
Sponsor
First posted
May 11, 2022
Start date
Feb 8, 2023
Primary completion
Feb 3, 2027 (estimated)
Completion
Feb 3, 2028 (estimated)
Last update
Nov 18, 2024

Study contacts

Sanjune Laurence Lee, MD
Contact
Sangjune.Lee@albertahealthservices.ca
587-231-6117

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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