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

NCT05370144 | Recruiting DMC

• 1 other identifier: NACEA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

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

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

Secondary Outcomes (5)

• To determine the rates of acute toxicities

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

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

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

• To compare pathological response rates to changes in tumor dimensions

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

• To compare pathological response rates to dysphagia scores

  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)

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

Study Arms (1)

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

Radiation: Hypofractionated radiotherapy

Interventions

Hypofractionated radiotherapy RADIATION

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.

Hypofractionated neoadjuvant concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Central Study Contacts

Sanjune Laurence Lee, MD

CONTACT

587-231-6117; Sangjune.Lee@albertahealthservices.ca

Amy Abel

CONTACT

amy.abel@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 11, 2022
• Study Start: February 8, 2023
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): February 3, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)