SWOG clinical trial number
S1714

A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients

Closed
Phase
Accrual
100%
Abbreviated Title
CIPN
Status Notes
S1714 will permanently close to accrual on November 15, 2021 at 12:00 pm PST.
Activated
03/01/2019
Participants
SWOG, ALL NCORP COMPONENTS AND SUBCOMPONENTS

Research committees

Symptom Control and Quality of Life
Breast Cancer
Lung Cancer
Early Therapeutics & Rare Cancers

Other Study Materials

Eligibility Criteria Expand/Collapse

- Stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer.

- Planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens within 14 days after reg. See Appendix 18.1 for the study-approved docetaxel and paclitaxel-based regimens.

- Treatment on another clinical trial is allowed if it is one of the study-approved regimens listed in Appendix 18.1. Additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study is allowed.

- No prior taxane, platinum, vinca alkaloid, or bortezomib-based chemotherapy regimen. (Carboplatin-containing regimen after reg as part of the docetaxel or paclitaxel regimen is allowed.)

- >/= 18 years of age.

- Must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish. Must: 1) agree to complete PROs at all scheduled assessments; and 2) complete the baseline PRO forms prior to reg.

- Pre-existing neuropathy is allowed (incl. diabetes and neurological conditions).

- Must agree to submit required specimens for defined translational medicine.

- Must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With consent, specimens must be submitted.

- Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Publication Information Expand/Collapse

2024

Risk Prediction Model for Taxane-Induced Peripheral Neuropathy in Patients with Early-Stage Cancer Receiving Taxane Therapy: SWOG S1714 (NCT# 03939481)

M Trivedi;J Unger;D Hershman;A Darke;D Hertz;T Brannagan;S Smith;B Schneider;W Irvin;A Hathaway;A Vander Woude;V Gudena;P Cabrera-Galean;M Orsted;M LeBlanc;NL Henry;MJ Fisch ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), oral; J Clin Oncol 42, 2024 (suppl 16; abstr 12005)

2023

Chemotherapy Induced Peripheral Neuropathy (CIPN) due to Paclitaxel versus Docetaxel in Patients with Early-Stage Breast Cancer Receiving Taxane Therapy: SWOG S1714 (NCT# 03939481)

M Trivedi;J Unger;D Hershman;A Darke;D Hertz;T Brannagan;S Smith;B Schneider;W Irvin;A Hathaway;A Vander Woude;V Gudena;NL Henry;M Fisch J Clin Oncol 41, 2023 (suppl 16; abstr 12003); ASCO Annual Meeting (June 2-6, 2023, Chicago, IL), oral

2022

Differences in clinician and patient assessment of baseline neuropathy in patients receiving taxane-based chemotherapy enrolled to SWOG S1714 (NCT# 03939481)

M Trivedi;J Unger;D Hershman;A Darke;D Hertz;T Brannagan;SJ Smith;W Irvin;A Hathaway;A Vander Woude;V Gudena;NL Henry;M Fisch J Clin Oncol 40, 2022 (suppl 16; abstr 12024), poster 270; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

Incidence of Chemotherapy Induced Peripheral Neuropathy in Patients with Early-Stage Breast Cancer Receiving Taxane Therapy: SWOG S1714 (NCT# 03939481)

M Trivedi;J Unger;D Hershman;A Darke;D Hertz;T Brannagan;S Smith;B Schneider;W Irvin;A Hathaway;A Vander Woude;V Gudena;NL Henry;M Fisch Cancer Research Vol 83, Issue 5_Suppl 1 March 2023; San Antonio Breast Cancer Symposium (Dec 6-10, 2022, San Antonio, TX, Spotlight Poster Discussion