Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
RACE-trial: Neoadjuvant Radiochemotherapy Versus Chemotherapy for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A Randomized Phase III Joint Study of the AIO, ARO and DGAV
Verified date | December 2023 |
Source | Universitätsmedizin Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing neoadjuvant radiochemotherapy with FLOT versus FLOT chemotherapy alone für patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ)
Status | Active, not recruiting |
Enrollment | 342 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, M0 or cT2 N+, M0 according to AJCC 8th edition 2. Patients* must be candidates for potential curative resection as determined by the treating surgeon 3. ECOG performance status 0-1 4. Age 18 years or above 5. Adequate hematologic function with absolute neutrophil count (ANC) = 1.5 x 10^9/l, platelets = 100 x 10^9/l and hemoglobin = 9.0 mg/dl 6. INR <1.5 and aPTT<1.5 x upper limit of normal (ULN) within 7 days prior to randomization 7. Adequate liver function as measured by serum transaminases (ASAT, ALAT) = 2.5 x ULN and total bilirubin = 1.5 x ULN 8. Adequate renal function with serum creatinine = 1.5 x ULN 9. QTc interval (Bazett*) = 440 ms 10. Written informed consent obtained before randomization 11. Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective*** contraceptive measures during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure. - *There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently. - ** formula for QTc interval calculation (Bazett): QTc= ((QT) ¯" (ms)" )/v(RR (sec))= ((QT) ¯" (ms)" )/v(60/(Frequence (1/min))) - *** highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). Exclusion Criteria: 1. Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs]) 2. Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible 3. Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03 4. Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled 5. Pregnant or lactating females 6. Patients medically unfit for chemotherapy and radiotherapy 7. Patients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted 8. Known hypersensitivity against 5-FU, folinc acid, oxaliplatin or docetaxel 9. Other known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel 10. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 11. Clinically significant valvular defect 12. Other severe internal disease or acute infection 13. Peripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03 14. Chronic inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
Germany | Unversity Hospital Mannheim | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim | Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of PFS between arms | to compare PFS in patients with resectable GEJ adenocarcinoma receiving perioperative FLOT alone versus perioperative FLOT combined with neoadjuvant radiochemotherapy where PFS ist defined as the time from randomization to disease progression or disease recurrence after surgery or death from any cause | up to 5 years | |
Secondary | Overall survival (OS) | Overall survival (OS) where OS is defined as the time from randomization to death from any cause | up to 5 years | |
Secondary | R0 resection rate | R0 resection rate where R0 resection is defined as microscopically margin negative resection with no gross or microscopic tumor remains in the areas of the primary tumor and/or samples regianal lymph nodes based on evaluation by the local pathologist. | after surgery, approx. 12 weeks after randomization | |
Secondary | Number of harvested lymph nodes | Number of harvested lymph nodes during surgery | after surgery, approx. 12 weeks after randomization | |
Secondary | Site of tumor relapse | Site of tumor relapse if tumor recurrence/relapse occurs | 5 years | |
Secondary | Overall survival rate at 1, 3 and 5 years | Overall survival rate is defined as the proportion of patients known to be alive at 1, 3 or 5 years after randomization | 1 year, 3 years, 5 years | |
Secondary | Patient reported outcomes: quality of life according to questionnaire EORTC-QLQ-C30 | quality of life scores according to validated questionnaires EORTC-QLQ-C30 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months | |
Secondary | Patient reported outcomes: quality of life according to questionnaire EORTC module OG25 | quality of life scores according to validated questionnaire EORTC module OG25 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months |
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