Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer

Phase 3 Terminated 221 enrolled University of Erlangen-Nürnberg Medical School Deutsche Krebshilfe e.V., Bonn (Germany) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

Timeline

Start: 2010-06
Primary completion: 2015-06
Completion: 2019-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “After an Interims analysis the Data Safety Monitoring board recommended this because no significant difference between the two arms was seen and was not expected with an reasonable recruitment of patients. No interruptions of the trial were made.”

paper CONCLUSION: Paclitaxel/cisplatin-CRT with a reduced RT-dose is not superior to standard fluorouracil/cisplatin-CRT. PMID 32044419 ↗

Publications

Fietkau R, Hecht M, Hofner B, Lubgan D, Iro H, Gefeller O, Rodel C, Hautmann MG, Kolbl O, Salay A, Rube C, Melchior P, Breinl P, Krings W, Gripp S, Wollenberg B, Keerl R, Schreck U, Siekmeyer B, Grabenbauer GG, Balermpas P; PacCis-Study Group. Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial. Radiother Oncol. 2020 Mar;144:209-217. doi: 10.1016/j.radonc.2020.01.016. Epub 2020 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cisplatin	Other / unclassified	20 mg/m2	—
Subject	Paclitaxel	Small molecule	20 mg/m2	—
Comparator	fluorouracil	Small molecule	600 mg/m2	—