PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

NCT01333033 | Completed Phase 2 Results

• 4 other identifiers: CALGB-80803CDR0000698428NCI-2011-02642U10CA180821
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 68

Brief Summary

RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer

Keywords

adenocarcinoma of the gastroesophageal junction; adenocarcinoma of the esophagus; stage IB esophageal cancer; stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Complete Pathological Response (pCR) of PET/CT Non-responders

  The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.

  Up to 5 years

Secondary Outcomes (4)

• PET/CT Response Between Treatment Arms

  Up to 5 years

• pCR Compared Between Induction Treatment Arms Among PET/CT Responders

  Up to 5 years

• pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious

  Up to 5 years

• Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group

  Up to 5 years

Study Arms (2)

Arm I (FOLFOX regimen)

EXPERIMENTAL

Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.

Drug: Oxaliplatin; Drug: Leucovorin Calcium; Drug: Fluorouracil; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Radiation: Radiation Therapy

Arm II (carboplatin + paclitaxel + radiation)

EXPERIMENTAL

Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT

Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

Interventions

Oxaliplatin DRUG

Given IV

Arm I (FOLFOX regimen)

Leucovorin Calcium DRUG

Given IV

Arm I (FOLFOX regimen)

Fluorouracil DRUG

Given IV

Arm I (FOLFOX regimen)

Carboplatin DRUG

Given IV

Arm I (FOLFOX regimen); Arm II (carboplatin + paclitaxel + radiation)

Paclitaxel DRUG

Given IV

Arm I (FOLFOX regimen); Arm II (carboplatin + paclitaxel + radiation)

Positron Emission Tomography PROCEDURE

Undergo PET/CT scan

Arm I (FOLFOX regimen)

Computed Tomography PROCEDURE

Undergo PET/CT scan

Arm I (FOLFOX regimen)

Radiation Therapy RADIATION

Undergo RT

Arm I (FOLFOX regimen); Arm II (carboplatin + paclitaxel + radiation)

Eligibility Criteria

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

* Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas types 1 and 2 * T1N1-3M0 or T2-4NanyM0 as determined by endoscopic ultrasound (EUS) and PET/CT (histologic confirmation of lymph involvement is not required); all disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field; no T4 tumor with clear evidence of invasion of the vertebral column, heart, great vessels, or tracheobronchial tree * All patients must have locoregional staging determined by endoscopic ultrasound (EUS) if technically feasible; endoscopy reports or subsequent gastrointestinal (GI) clinic note should clearly state both the T and N stage * No evidence of distant metastases (as determined by EUS or PET/CT) * Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible * Patient must have pre-resection tissue available for central pathology review, in case that the patient has a pCR at the time of surgical resection to confirm diagnosis * Patients must have an fludeoxyglucose F 18 (FDG)-avid tumor with a maximum standard uptake value (SUVmax) of \>= 5.0 on baseline PET/CT scan of primary tumor; baseline PET/CT scan should be performed; if it is necessary to repeat baseline PET/CT scan, reimbursement information is available * No prior malignancy within 5 years of registration, with the exception of basal or squamous cell skin cancers, or in situ bladder or cervical cancer; patients with prior malignancy treated with surgery only and disease free for more than 5 years are eligible; however, no prior thoracic radiation therapy (RT) or abdominal RT or chemotherapy allowed * No known contraindication to the use of fluorouracil, taxanes, or platinum compounds * No history of severe hypersensitivity reaction to Cremophor EL * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must be non-pregnant and non-nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 72 hours prior to randomization; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \>= 12 consecutive months; or women on hormone replacement therapy \[HRT\] with documented serum follicle stimulating hormone \[FSH\] level \> 35mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential * Absolute neutrophil count (ANC) \>= 1,500/μL * Platelet count \>= 100,000/μL * Bilirubin =\< 1.5 times upper limit of normal (ULN) * Calculated creatinine clearance \>= 60 mL/min * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 times ULN

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (68)

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817-3169, United States

Location

Kuakini Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Oncare Hawaii, Incorporated - Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-3785, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58102, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Location

Alle-Kiski Medical Center

Natrona Heights, Pennsylvania, 15065, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Center for Cancer Treatment & Prevention at Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Saint Joseph's Hospital

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, 54548, United States

Location

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, 54481, United States

Location

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, 54481, United States

Location

Diagnostic and Treatment Center

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

Related Publications (2)

• Goodman KA, Ou FS, Hall NC, Bekaii-Saab T, Fruth B, Twohy E, Meyers MO, Boffa DJ, Mitchell K, Frankel WL, Niedzwiecki D, Noonan A, Janjigian YY, Thurmes PJ, Venook AP, Meyerhardt JA, O'Reilly EM, Ilson DH. Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial. J Clin Oncol. 2021 Sep 1;39(25):2803-2815. doi: 10.1200/JCO.20.03611. Epub 2021 Jun 2.

  PMID: 34077237 DERIVED

• Ku GY, Bains MS, Park DJ, Janjigian YY, Rusch VW, Rizk NP, Yoon SS, Millang B, Capanu M, Goodman KA, Ilson DH. Phase II study of bevacizumab and preoperative chemoradiation for esophageal adenocarcinoma. J Gastrointest Oncol. 2016 Dec;7(6):828-837. doi: 10.21037/jgo.2016.08.09.

  PMID: 28078107 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Carboplatin; Paclitaxel; Magnetic Resonance Spectroscopy; Radiotherapy

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics

Results Point of Contact

• Title: Karyn Goodman, M.D.
• Organization: Alliance for Clinical Trials in Oncology

goodmank@mskcc.org

(212) 639-3983

Study Officials

• Karyn A. Goodman, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2023
• Last Updated: April 13, 2023
• Results First Posted: November 3, 2021

Record last verified: 2023-04

Locations

US (68)