Induction Chemotherapy for Locally Advanced Esophageal Cancer

NCT03110926 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UGIE 17037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival rate

  Evaluate the 2-year disease-free survival rate in patients who receive induction chemotherapy with mFOLFOX6 followed by standard chemoradiation and surgery.

  2 years

Secondary Outcomes (4)

• Pathologic examination

  2 years

• Toxicities as Assessed by CTCAE v4.0

  25-29 weeks

• Overall survival

  2 years

• Overall disease-free survival

  2 years

Study Arms (1)

Induction Chemotherapy /Chemoradiation

EXPERIMENTAL

mFOLFOX6 for 3 cycles - Oxaliplatin 85 mg/m2, 5-fluorouracil 2400mg/m2/46 hours, 5-fluorouracil bolus 400mg/m2 and leucovorin 400 mg/m2, then chemoradiation for 5 cycles - Carboplatin AUC 2mg/mL/min, Paclitaxel 50 mg/m2 and radiation therapy.

Drug: mFOLFOX6; Combination Product: Chemoradiation

Interventions

mFOLFOX6 DRUG

Induction Chemotherapy

Also known as: Oxaliplatin, Leucovorin, 5-FU

Induction Chemotherapy /Chemoradiation

Chemoradiation COMBINATION_PRODUCT

Chemoradiation

Also known as: Carboplatin, Paclitaxel, External Beam Radiation Therapy

Induction Chemotherapy /Chemoradiation

Eligibility Criteria

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

You may qualify if:

• Must have histologically proven adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the esophagus, GE junction and/or gastric cardia.
• Must have potentially resectable disease.
• Must have ECOG performance status 0 or 1.
• Must have adequate organ function as defined by the following criteria:
• ANC ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Creatinine (Cr) ≤ 1.5 mg and/or creatinine clearance ≥ 60cc/min.
• Total bilirubin must be ≤ 1.5 x ULN unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin.
• Alkaline phosphatase must be ≤ 2 x ULN.
• AST \& ALT must be ≤ 3 x ULN.
• Men and women of reproductive potential must agree to use an effective contraception method
• Must be willing and able to provide written informed consent
• Must be ≥ 18 years or older

You may not qualify if:

• Prior chemotherapy, thoracic radiotherapy or prior surgical resection for an esophageal tumor.
• Known distant metastases.
• Patients with prior malignancies are eligible if they have been disease-free for \> 5 years and are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization.
• Known ≥ grade 2 neuropathy.
• Known non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.
• Known psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements.
• Women who are pregnant or nursing.
• Women and men of reproductive potential who are expecting to conceive or father children.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (6)

• van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

  PMID: 22646630 BACKGROUND

• Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.

  PMID: 26254683 BACKGROUND

• Ajani JA, Komaki R, Putnam JB, Walsh G, Nesbitt J, Pisters PW, Lynch PM, Vaporciyan A, Smythe R, Lahoti S, Raijman I, Swisher S, Martin FD, Roth JA. A three-step strategy of induction chemotherapy then chemoradiation followed by surgery in patients with potentially resectable carcinoma of the esophagus or gastroesophageal junction. Cancer. 2001 Jul 15;92(2):279-86. doi: 10.1002/1097-0142(20010715)92:23.0.co;2-2.

  PMID: 11466680 BACKGROUND

• Bains MS, Stojadinovic A, Minsky B, Rusch V, Turnbull A, Korst R, Ginsberg R, Kelsen DP, Ilson DH. A phase II trial of preoperative combined-modality therapy for localized esophageal carcinoma: initial results. J Thorac Cardiovasc Surg. 2002 Aug;124(2):270-7. doi: 10.1067/mtc.2002.122545.

  PMID: 12167786 BACKGROUND

• Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB 3rd, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. J Clin Oncol. 2016 Aug 10;34(23):2736-42. doi: 10.1200/JCO.2015.65.5092. Epub 2016 Jul 5.

  PMID: 27382098 BACKGROUND

• Finley KA. Observations of bluegills fed selenium-contaminated Hexagenia nymphs collected from Belews Lake, North Carolina. Bull Environ Contam Toxicol. 1985 Dec;35(6):816-25. doi: 10.1007/BF01636593. No abstract available.

  PMID: 4074950 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Chemoradiotherapy; Carboplatin; Paclitaxel

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)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Richard Dunne, MD

  University of Rochester Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 12, 2017
• Study Start: June 19, 2017
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)