Recruiting

Neoadjuvant Chemoradiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05370144

Conditions

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated radiotherapy

Study Details

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

Study ID

NCT05370144

Start date

Feb 8, 2023

Status verified date

Oct, 2024

Completion date

Feb 3, 2028

Anticipated

Primary completion date

Feb 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Hypofractionated 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.

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) ]

Central Contacts and Locations

Locations

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

Recruiting

Calgary, Alberta, Canada

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Nov 18, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2024-11-18.