drugset / Trial / NCT01333033
PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
Phase 2
Completed
257 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-11
- Completion
- 2023-04-01
Outcome
Missed primary endpoint
registry analysis (superiority test); FOLFOX Non-Responder vs CP Non-Responder; p = 1.0; Fisher Exact NCT01333033 ↗
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |