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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01333033
Recruitment Status : Active, not recruiting
First Posted : April 11, 2011
Results First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Drug: Oxaliplatin Drug: Leucovorin Calcium Drug: Fluorouracil Drug: Carboplatin Drug: Paclitaxel Procedure: Positron Emission Tomography Procedure: Computed Tomography Radiation: Radiation Therapy Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
Actual Study Start Date : July 2011
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (FOLFOX regimen)
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
Given IV

Drug: Leucovorin Calcium
Given IV

Drug: Fluorouracil
Given IV

Drug: Carboplatin
Given IV

Drug: Paclitaxel
Given IV

Procedure: Positron Emission Tomography
Undergo PET/CT scan

Procedure: Computed Tomography
Undergo PET/CT scan

Radiation: Radiation Therapy
Undergo RT
Experimental: Arm II (carboplatin + paclitaxel + radiation)
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
Given IV

Drug: Paclitaxel
Given IV

Radiation: Radiation Therapy
Undergo RT


Outcome Measures
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Primary Outcome Measures :
  1. Complete Pathological Response (pCR) of PET/CT Non-responders [ Time Frame: Up to 5 years ]
    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.


Secondary Outcome Measures :
  1. PET/CT Response Between Treatment Arms [ Time Frame: Up to 5 years ]
    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).

  2. pCR Compared Between Induction Treatment Arms Among PET/CT Responders [ Time Frame: Up to 5 years ]

    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.


  3. pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious [ Time Frame: Up to 5 years ]

    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.


  4. Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group [ Time Frame: Up to 5 years ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333033


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Karyn A. Goodman, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01333033    
Other Study ID Numbers: CALGB-80803
CDR0000698428 ( Registry Identifier: NCI Physician Data Query )
NCI-2011-02642 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA180821 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2011    Key Record Dates
Results First Posted: November 3, 2021
Last Update Posted: November 3, 2021
Last Verified: October 2021
Keywords provided by Alliance for Clinical Trials in Oncology:
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
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Leucovorin
Paclitaxel
 Carboplatin
Fluorouracil
Oxaliplatin
Calcium
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic