NCT00991094

Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

Recruiting now Last updated 2 January 2026

What this trial tests

trial testing Quality-of-Life Assessment in Breast Carcinoma in 5,000 participants. Currently enrolling.

Timeline

27 May 2005

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	27 May 2005
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Breast Carcinoma — all drugs for Breast Carcinoma →
• Esophageal Carcinoma — all drugs for Esophageal Carcinoma →
• Genitourinary System Carcinoma — all drugs for Genitourinary System Carcinoma →
• Head and Neck Carcinoma — all drugs for Head and Neck Carcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Breast Carcinoma or Esophageal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Toward a model-based patient selection strategy for proton therapy: External validation of photon-derived normal tissue complication probability models in a head and neck proton therapy cohort.
   Blanchard P, Wong AJ, Gunn GB, Garden AS, et al · · 2016 · cited 84× · PMID 27641784 · DOI 10.1016/j.radonc.2016.08.022
2. Long-term outcomes after proton therapy, with concurrent chemotherapy, for stage II-III inoperable non-small cell lung cancer.
   Nguyen QN, Ly NB, Komaki R, Levy LB, et al · · 2015 · cited 74× · PMID 26028228 · DOI 10.1016/j.radonc.2015.05.014
3. Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC.
   Gjyshi O, Xu T, Elhammali A, Boyce-Fappiano D, et al · · 2021 · cited 36× · PMID 33198942 · DOI 10.1016/j.jtho.2020.10.013
4. Intensity-modulated proton therapy for oropharyngeal cancer reduces rates of late xerostomia.
   Cao J, Zhang X, Jiang B, Chen J, et al · · 2021 · cited 23× · PMID 33839202 · DOI 10.1016/j.radonc.2021.03.036
5. Proton Beam Therapy for Head and Neck Carcinoma of Unknown Primary: Toxicity and Quality of Life.
   Sherry AD, Pasalic D, Gunn GB, Fuller CD, et al · · 2021 · cited 14× · PMID 34285950 · DOI 10.14338/ijpt-20-00034.1
6. FDG uptake correlates with recurrence and survival after treatment of unresectable stage III non-small cell lung cancer with high-dose proton therapy and chemotherapy.
   Xiang ZL, Erasmus J, Komaki R, Cox JD, et al · · 2012 · cited 12× · PMID 22929048 · DOI 10.1186/1748-717x-7-144
7. Particle Therapy: Clinical Applications and Biological Effects.
   Kiseleva V, Gordon K, Vishnyakova P, Gantsova E, et al · · 2022 · cited 6× · PMID 36556436 · DOI 10.3390/life12122071
8. Survival outcomes and toxicity of adjuvant immunotherapy after definitive concurrent chemotherapy with proton beam radiation therapy for patients with inoperable locally advanced non-small cell lung carcinoma.
   Corrigan KL, Xu T, Sasaki Y, Lin R, et al · · 2024 · cited 2× · PMID 38311031 · DOI 10.1016/j.radonc.2024.110121