PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
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| ClinicalTrials.gov Identifier: NCT01333033 |
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Recruitment Status :
Active, not recruiting
First Posted : April 11, 2011
Last Update Posted : July 2, 2019
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Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
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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 |
Show detailed description
| 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
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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
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Drug: Carboplatin
Given IV Drug: Paclitaxel Given IV Radiation: Radiation Therapy Undergo RT |
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 ]
Secondary Outcome Measures :
- PET/CT response between treatment arms [ Time Frame: Up to 5 years ]
- pCR compared between induction treatment arms among PET/CT responders [ Time Frame: Up to 5 years ]
- pCR compared among non-responders between induction treatment arms if treatment regimens are found to be efficacious [ Time Frame: Up to 5 years ]
- PFS among PET/CT non-responders within each induction treatment group [ Time Frame: 8 months ]
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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
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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Last Update Posted: | July 2, 2019 |
| Last Verified: | July 2019 |
Keywords provided by Alliance for Clinical Trials in Oncology:
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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 |