Not yet recruiting NCT07603375
Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin).
- Who it may be relevant to
- Registry conditions: Esophageal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-arm Study of Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
Overview
The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.
Interventions
- Drug FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Modified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)
Primary outcome measures
- Number of participants with Clinical complete response (cCR) [Time frame: approximately 36 weeks]
Secondary outcome measures (10)
- Number of participants with pathologic complete response (pCR) [Time frame: approximately 36 weeks]
- Number of participants who complete both chemoradiation and chemotherapy [Time frame: approximately 36 weeks]
- Number of participants with local control [Time frame: up to 5 years]
- Number of participants with Disease free survival [Time frame: up to 5 years]
- Time to distant metastasis [Time frame: up to 5 years]
- Overall survival [Time frame: up to 5 years]
- Number of participants with Local control [Time frame: up to 5 years]
- Disease free survival [Time frame: up to 5 years]
- Time to distant metastasis [Time frame: up to 5 years]
- Overall survival [Time frame: up to 5 years]
Eligibility criteria
Inclusion criteria
- Subject must be able to provide study specific informed consent prior to study entry
- Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II);
- Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition;
- Complete history and physical examination within 21 days of signing consent;
- Staging whole-body FDG-PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography) scan with or without contrast (preferred) or chest/abdominal (CT with contrast) confirming there is no evidence of metastatic disease must be obtained within 45 days of study enrollment
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
- Subjects must be appropriate candidates for planned chemoradiation (concurrent carboplatin/paclitaxel) and chemotherapy (FLOT, m-FOLFOX-6) as determined by the treating radiation oncologist, medical oncologist, and surgical oncologist.
- Adequate hematologic, renal, and hepatic function within 14 days of initiation of therapy
Exclusion criteria
- Cervical esophageal cancers arising 15-18 cm from the incisors.
- Esophageal squamous cell carcinoma.
- Patients with T4b disease according to the AJCC 8th Edition.
- Definitive clinical or radiologic evidence of metastatic disease.
- Has had prior systemic therapy or radiation therapy for the current diagnosis.
- Prior thoracic radiotherapy for any reason that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Severe, active co-morbidity defined as follows:
- Active uncontrolled infection requiring IV antibiotics;
- Pregnant and/or nursing subjects;
- HIV positive with CD4 count < 200 cells/microliter. Note that subjects who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT07603375 · Pro00120182