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Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT01333033

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

A Phase 2 study testing Oxaliplatin, Leucovorin Calcium and Fluorouracil in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 68 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxaliplatin, Leucovorin Calcium and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
68 sitesUnited States
Study dates
Jul 2011to 1 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

United States68 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncare Hawaii, Incorporated - Pali Momi

    ‘Aiea, Hawaii, 96701

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

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

    Chapel Hill, North Carolina, 27599-7295

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

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

    Columbus, Ohio, 43210-1240

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817-3169

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Forbes Regional Hospital

    Monroeville, Pennsylvania, 15146

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • Alle-Kiski Medical Center

    Natrona Heights, Pennsylvania, 15065

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

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Marshfield Clinic at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Saint Michael's Hospital Cancer Center

    Stevens Point, Wisconsin, 54481

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Diagnostic and Treatment Center

    Weston, Wisconsin, 54476

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

Other trials in United States

About this study

Official title: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

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.

Read the detailed description

OBJECTIVES:

Primary

  • To induce a complete pathologic response (pCR) rate of 20% in positron emission tomography (PET) scan non-responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then crossover to the other regimen during radiotherapy.

Secondary

  • To compare PET/CT response between induction treatment arms.
  • To compare pCR between induction treatment arms among PET/CT scan responders.
  • To directly compare pCR between induction treatment arms among non-responders if both treatment regimens are found to be efficacious.
  • To determine 8-month progression-free survival (PFS) in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy.
  • Estimate the PFS and overall survival (OS) curves, overall and among PET responders and PET/CT non-responders by induction treatment.
  • To determine the rate of postoperative anastomotic leak after neoadjuvant chemotherapy followed by chemoradiation.
  • To evaluate immunohistochemistry and RT-PCR of ERCC1, and genetic polymorphisms of ERCC1, XPD, and XRCC1.
  • To evaluate status and levels of methylation of nine candidate biomarker genes as well as expression levels of selected specific microRNAs, which will be correlated with chemoradiation response.
  • To compare the quality of life (QOL) of responders and nonresponders (as determined by PET/CT scanning) to presurgical treatment for esophageal cancer, in terms of global QOL, physical symptoms, physical functioning, and emotional well-being.
  • To examine the association between OS and QOL in esophageal cancer patients treated with chemotherapy, chemoradiation therapy, and surgery.

OUTLINE: This is a multicenter study. Patients are stratified according to T-stage (T1-2 vs T3-4) and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: 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 radiotherapy (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.
  • Arm II: 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.

Within 4-10 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgery at the discretion of the treating team.

Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Patients may also complete quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

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
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01333033
Study groupRoleWhat they receive
Arm I (FOLFOX regimen)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. PET/CT Response Between Treatment Arms

    A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by >=35%, as measured by maximum standardized uptake value (SUVmax).

    Measured: Up to 5 years

  2. pCR Compared Between Induction Treatment Arms Among PET/CT Responders

    A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by >=35%, as>

    >>

    >>

    >> measured by maximum standardized uptake value (SUVmax). 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.

    Measured: Up to 5 years

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

    A Complete Pathological Response (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. A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.>

    >>>

    >

    >>> Among the patients who completed induction therapy and did not respond, the percentage of patients reporting a pCR in each arm were compared.

    Measured: Up to 5 years

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

    A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.

    Among the patients who completed induction therapy and did not respond, the progression free survival in each arm were compared. PFS will be measured from study entry until documented progression or death from any cause. PFS will be estimated using the method of Kaplan and Meier.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2015
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01333033
Sponsor's protocol ID
CALGB-80803
Other IDs
CDR0000698428, NCI-2011-02642, U10CA180821
Status last verified
Apr 2023
First submitted
7 Apr 2011
Last updated
13 Apr 2023
Data monitoring committee
No

Publications

  • 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.

    PubMed 34077237

  • 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.

    PubMed 28078107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Leucovorin Calcium and Fluorouracil in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 68 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Pathological Response (pCR) of PET/CT Non-responders (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01333033, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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