Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2 Completed 43 enrolled Radiation Therapy Oncology Group NRG Oncology · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

Timeline

Start: 2003-09
Primary completion: 2007-03
Completion: 2016-12

Outcome

Missed primary endpoint

paper the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%). PMID 21507583 ↗

Publications

Results Swisher SG, Winter KA, Komaki RU, Ajani JA, Wu TT, Hofstetter WL, Konski AA, Willett CG. A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1967-72. doi: 10.1016/j.ijrobp.2011.01.043. Epub 2011 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	15 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	300 mg/m2	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	300 ug	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	480 ug	Subcutaneous