ACTIVE_NOT_RECRUITING

Induction FLOT With CROSS CRT for Esophageal Cancer

Conditions

Adenocarcinoma Esophagus Adenocarcinoma of the Gastroesophageal Junction Resectable

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates a novel regimen of induction chemotherapy using a combination of docetaxel, oxaliplatin, and leucovorin, with short term infusional 5-FU (FLOT), given prior to chemoradiotherapy with concurrent carboplatin and paclitaxel, as neoadjuvant therapy prior to definitive surgical resection for patients with adenocarcinoma of the esophagus or gastroesophageal junction

Official Title

Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients With Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Quick Facts

Study Start:2020-04-08

Study Completion:2027-04-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04028167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be a male or female aged 18-100. 4. Have newly diagnosed, resectable cT3-T4 or node positive adenocarcinoma of the esophagus or gastroesophageal junction as assessed by CT or MRI of the chest, abdomen and pelvis and by endoscopic ultrasound, with pathologic diagnosis obtained within 3 months of signing consent, without delivery of prior chemotherapy or radiation therapy. 5. Subjects must be previously untreated with systemic chemotherapy or radiation therapy. 6. Subjects must be deemed a candidate for trimodality therapy (radiation, chemotherapy and surgery) based upon multidisciplinary evaluation with plan for preoperative chemoradiation followed by surgical resection. 7. ECOG performance status score of 0-1 (See Appendix). 8. Adequate bone marrow function (WBC \> 3 x 109/L; hemoglobin \> 9 g/dl; platelets \> 100 x 109/L) 9. Adequate liver function (total bilirubin \< 1.5 x upper limit of normal, AST \< 3 x upper limit of normal, and ALT \< 3 x upper limit of normal) 10. Serum creatinine \< 1.5 x ULN or calculated creatinine clearance \> 50 mL/min (using the Cockcroft-Gault formula) 11. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment and must agree to follow instructions for method(s) of contraception for the duration of the study period and at least 3 months after the last dose of chemotherapy is administered. For the purpose of this study, a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal ligation * vasectomized partner * sexual abstinence 12. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but still must undergo pregnancy testing as described in this section. 13. Males who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of the study period and for at least 3 months (duration of sperm turnover) after the last dose of chemotherapy is administered. In addition, males must be willing to refrain from sperm donation during this time.	1. Subjects with metastatic or inoperable esophageal or gastroesophageal junction adenocarcinoma. 2. Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adenosquamous carcinoma. 3. Prior treatment with chemotherapy or radiation therapy for esophageal or gastroesophageal adenocarcinoma. 4. Prior malignancy active within the previous 3 years that is felt to exclude the patient from definitive therapy of esophageal or gastroesophageal cancer, or if prior cancer therapy is felt by the investigator to significantly increase toxicity risk from the study regimen. 5. Prior history of thoracic or abdominal radiotherapy that would overlap with the planned treatment volume. 6. Active collagen vascular disease. 7. Subjects with \> Grade 1 peripheral neuropathy. 8. Any serious or uncontrolled medical disorder or active infection, that in the opinion of the investigator may increase the risk associated with study participation, study treatment administration or would impair the ability of the subject to receive study treatment. 9. Known history of hepatitis B or hepatitis C. 10. Clinically unstable cardiac disease including unstable angina, congestive heart failure, ventricular arrhythmia or known prior QTc \> 450msec. 11. History of allergy or hypersensitivity to any of the study drugs or study drug components. 12. Any contraindications to any of the study drugs of the chemotherapy regimens (FLOT or carboplatin/paclitaxel) selected by the investigator. Investigators should refer to the local package insert of the chemotherapy drugs. 13. Prisoners or subjects who are involuntarily incarcerated. 14. History of psychiatric illness that precludes completion of informed consent process, or which is deemed by the investigators as potentially influencing study compliance. 15. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 16. Pregnant or breast-feeding women.

Inclusion Criteria

Exclusion Criteria

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a male or female aged 18-100.
4. Have newly diagnosed, resectable cT3-T4 or node positive adenocarcinoma of the esophagus or gastroesophageal junction as assessed by CT or MRI of the chest, abdomen and pelvis and by endoscopic ultrasound, with pathologic diagnosis obtained within 3 months of signing consent, without delivery of prior chemotherapy or radiation therapy.
5. Subjects must be previously untreated with systemic chemotherapy or radiation therapy.
6. Subjects must be deemed a candidate for trimodality therapy (radiation, chemotherapy and surgery) based upon multidisciplinary evaluation with plan for preoperative chemoradiation followed by surgical resection.
7. ECOG performance status score of 0-1 (See Appendix).
8. Adequate bone marrow function (WBC \> 3 x 109/L; hemoglobin \> 9 g/dl; platelets \> 100 x 109/L)
9. Adequate liver function (total bilirubin \< 1.5 x upper limit of normal, AST \< 3 x upper limit of normal, and ALT \< 3 x upper limit of normal)
10. Serum creatinine \< 1.5 x ULN or calculated creatinine clearance \> 50 mL/min (using the Cockcroft-Gault formula)
11. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment and must agree to follow instructions for method(s) of contraception for the duration of the study period and at least 3 months after the last dose of chemotherapy is administered. For the purpose of this study, a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
* oral
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation:
* oral
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal ligation
* vasectomized partner
* sexual abstinence
12. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but still must undergo pregnancy testing as described in this section.
13. Males who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of the study period and for at least 3 months (duration of sperm turnover) after the last dose of chemotherapy is administered. In addition, males must be willing to refrain from sperm donation during this time.

1. Subjects with metastatic or inoperable esophageal or gastroesophageal junction adenocarcinoma.
2. Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adenosquamous carcinoma.
3. Prior treatment with chemotherapy or radiation therapy for esophageal or gastroesophageal adenocarcinoma.
4. Prior malignancy active within the previous 3 years that is felt to exclude the patient from definitive therapy of esophageal or gastroesophageal cancer, or if prior cancer therapy is felt by the investigator to significantly increase toxicity risk from the study regimen.
5. Prior history of thoracic or abdominal radiotherapy that would overlap with the planned treatment volume.
6. Active collagen vascular disease.
7. Subjects with \> Grade 1 peripheral neuropathy.
8. Any serious or uncontrolled medical disorder or active infection, that in the opinion of the investigator may increase the risk associated with study participation, study treatment administration or would impair the ability of the subject to receive study treatment.
9. Known history of hepatitis B or hepatitis C.
10. Clinically unstable cardiac disease including unstable angina, congestive heart failure, ventricular arrhythmia or known prior QTc \> 450msec.
11. History of allergy or hypersensitivity to any of the study drugs or study drug components.
12. Any contraindications to any of the study drugs of the chemotherapy regimens (FLOT or carboplatin/paclitaxel) selected by the investigator. Investigators should refer to the local package insert of the chemotherapy drugs.
13. Prisoners or subjects who are involuntarily incarcerated.
14. History of psychiatric illness that precludes completion of informed consent process, or which is deemed by the investigators as potentially influencing study compliance.
15. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
16. Pregnant or breast-feeding women.

Contacts and Locations

Principal Investigator

Jeffrey Olsen, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Hospital

Aurora, Colorado, 80045

United States

UCHealth Southern Colorado - Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

UCHealth Southern Colorado - Memorial Hospital North

Colorado Springs, Colorado, 80920

United States

UCHealth Northern Colorado - Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

UCHealth Northern Colorado - Harmony Campus

Fort Collins, Colorado, 80528

United States

UCHealth Northern Colorado - Greeley Hospital

Greeley, Colorado, 80634

United States

UCHealth Northern Colorado Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Jeffrey Olsen, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-08

Study Completion Date2027-04-19

Study Record Updates

Study Start Date2020-04-08

Study Completion Date2027-04-19

Terms related to this study

Keywords Provided by Researchers

Resectable

Additional Relevant MeSH Terms

Adenocarcinoma Esophagus
Adenocarcinoma of the Gastroesophageal Junction