PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Esophageal Cancer Nuclear Scans

Drug Information available for: Fluorouracil Leucovorin calcium Paclitaxel Carboplatin Oxaliplatin Levoleucovorin

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:

pCR rate of PET/CT non-responders within each induction treatment group each induction treatment group [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PET/CT response between treatment arms [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
pCR compared between induction treatment arms among PET/CT responders [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
pCR compared among non-responders between induction treatment arms if treatment regimens are found to be efficacious [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
PFS among PET/CT non-responders within each induction treatment group [ Time Frame: 8 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	204
Study Start Date:	July 2011
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333033

Show 68 Study Locations

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	Karyn A. Goodman, MD	Memorial Sloan Kettering Cancer Center

More Information


Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT01333033 History of Changes
Other Study ID Numbers:	CALGB-80803 CDR0000698428 NCI-2011-02642 U10CA180821
Study First Received:	April 7, 2011
Last Updated:	July 1, 2016
Health Authority:	United States: Institutional Review Board

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:


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 Paclitaxel Oxaliplatin	Albumin-Bound Paclitaxel Carboplatin Fluorouracil Levoleucovorin Leucovorin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors

ClinicalTrials.gov processed this record on September 23, 2016