Phase III randomized trial of image-guided bone marrow-sparing intensity modulated radiation therapy (IG-BMS-IMRT) for locoregionally advanced cervical cancer: The INTERTECC-3 trial.

Authors

null

Loren K. Mell

University of California San Diego Moores Cancer Center, La Jolla, CA

Loren K. Mell , Igor Sirak , Lorraine Portelance , Aaron Howard Wolfson , Alexandra J. Stewart , Dayanand Sharma , Denis Princ , Umesh Mahantshetty , Mitsuhiro Nakamura , Kimiko Hirata , Stephen F Kry , Lichun Wei , Ronghui Xu , Kaveh Zakeri , Elena Sojourner , Kevin Moore , Michael T. McHale , Cheryl C. Saenz , Catheryn M. Yashar , Arno James Mundt

Organizations

University of California San Diego Moores Cancer Center, La Jolla, CA, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, University of Miami Miller School of Medicine, Miami, FL, Royal Surrey County Hospital, Guildford, United Kingdom, Department of Radiation Oncology, Dr BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India, Masaryk Memorial Cancer Institute, Brno, Czech Republic, Tata Memorial Centre, Mumbai, India, Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Kyoto University, Kyoto, Japan, The University of Texas MD Anderson Cancer Center, Houston, TX, Fourth Military Medical University, Xi'an, China, University of California, San Diego, La Jolla, CA, Center for Translational Radiation Medicine and Imaging, La Jolla, CA, University of California San Diego Medical Center, La Jolla, CA

Research Funding

NIH

Background: Cervical cancer is a leading cause of cancer death in women worldwide. Image-guided bone marrow-sparing intensity modulated radiation therapy (IG-BMS-IMRT) has shown potential to reduce acute toxicity of chemoradiotherapy and improve chemotherapy delivery in phase I and II trials (Mell LK, Sirák I, Wei L, et al. Bone Marrow-sparing IMRT With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2). Int J Radiat Oncol Biol Phys 2017;97:536-545. Mell LK, Saenz CC, Yashar CM, et al. Phase I Trial of Bone Marrow Sparing IMRT With Concurrent Cisplatin and Gemcitabine in Stage IB-IVA Cervical Cancer (abstr.) Int J Radiat Oncol Biol Phys 2016; 96: S14.). Methods: INTERTECC-3 is a randomized phase III trial designed to test the effect of IG-BMS-IMRT on progression-free survival (PFS) for women with unresected FIGO stage IB-IVA cervical carcinoma (clinicaltrials.gov #NCT01554397). It presently involves centers in the U.S., Czech Republic, U.K., India, Japan, and China. Women are randomized 3:2 to either (A) IG-BMS-IMRT or (B) standard chemoradiation, with 6 cycles of concurrent cisplatin (40 mg/m2) weekly in both arms. Secondary objectives are to compare overall survival, treatment-related toxicity, disease recurrence, quality of life, chemotherapy delivery, and radiation quality assurance. Planning objectives require maintaining pelvic marrow and active marrow mean doses < 27 Gy and < 28.5 Gy respectively. Correlative studies involve longitudinal collection of magnetic resonance restriction spectrum imaging and 18F-fluorothydimine positron emission tomography scans to assess imaging biomarkers of treatment response in select patients. 415 women will be enrolled to determine if IG-BMS-IMRT improves the median PFS from 3.2 to 5.0 years with 80% power and alpha = 0.05. INTERTECC-3 opened in the U.S. and Czech Republic in 2016. To date, 17 patients have been randomized. The trial will be activated at additional international sites in late 2017 and 2018. We are seeking to recruit sites who wish to collaborate. Clinical trial information: NCT01554397

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

NCT01554397

Citation

J Clin Oncol 35, 2017 (suppl; abstr TPS5600)

DOI

10.1200/JCO.2017.35.15_suppl.TPS5600

Abstract #

TPS5600

Poster Bd #

422a

Abstract Disclosures