Breast CarcinomaNCT00991094
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
An observational study of Breast Carcinoma and Esophageal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Esophageal Carcinoma, Genitourinary System Carcinoma
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2005to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for radiation treatment with protons at University of Texas M. D. Anderson Cancer Center (UTMDACC)
Who may be able to join
- All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol
- Patients must sign a study-specific consent form prior to study entry
Who cannot join
- Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Steven J. Frank, 713-563-2300
Steven J. Frank
About this study
Official title: Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.
II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.
SECONDARY OBJECTIVES:
- To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.
II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).
OUTLINE:
Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.
- Conditions
- Breast Carcinoma, Esophageal Carcinoma, Genitourinary System Carcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Esophageal Neoplasms, Hematologic Neoplasms, Lung Neoplasms, Central Nervous System Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete questionnaires
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire) | Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicities data in patients treated with proton therapy
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. Upon analysis, the distribution of observed toxicity scores for each acute normal-tissue endpoint will be reported.
Measured: Up to 90 days after end of treatment
Late toxicities data in patients treated with proton therapy
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade >= 2 late toxicity). The log-rank test will be used to compare event times in subgroups of patients with different dosimetric characteristics of treatment (e.g. portion of lung receiving > 20 Gy: <= 40% vs > 40%). In addition, normal-tissue complication probability models will be fitted to data corresponding to incidence of a late endpoint within a specified time frame, with analysis limited to patients having the specified follow-up (e.g. incidence of grade >= 2 late rectal bleeding within 2 years among patients followed for 2 years post-treatment).
Measured: Starting 90 days or more after the end of radiotherapy
Dose-response relationships for normal tissue toxicity after proton therapy
Relevant dose-volume response models from the literature, such as the Lyman model, the parallel model, or the critical-element model will be fitted to the data when possible, and model parameter estimates reported. Confidence intervals for model parameter estimates will be derived using the profile-likelihood method.
Measured: Up to 3 months after therapy
Secondary outcomes (1)
Symptom burden
Will be documented and compared using the M.D. Anderson Symptom Inventory (MDASI). The initial analysis for symptom data will be primarily descriptive in nature, and will include frequencies, proportions, means, medians, standard deviations, ranges, interquartile ranges, confidence intervals for the means, and box and whisker plots. Potential differences in symptom development between patients and between treatment variables will be explored using longitudinal analysis performed with mixed models.
Measured: Up to 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study start27 May 2005
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven J Frank, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991094
- Sponsor's protocol ID
- PCR05-0207
- Other IDs
- NCI-2020-08092, PCR05-0207
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2009
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gjyshi O, Xu T, Elhammali A, Boyce-Fappiano D, Chun SG, Gandhi S, Lee P, Chen AB, Lin SH, Chang JY, Tsao A, Gay CM, Zhu XR, Zhang X, Heymach JV, Fossella FV, Lu C, Nguyen QN, Liao Z. Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC. J Thorac Oncol. 2021 Feb;16(2):269-277. doi: 10.1016/j.jtho.2020.10.013. Epub 2020 Oct 22.
PubMed 33198942
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
- ClinicalTrials.gov ID
- NCT00991094
- Acronym / sponsor ID
- PCR05-0207
- Conditions
- Breast Carcinoma, Esophageal Carcinoma, Genitourinary System Carcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 May 2005 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.
II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.
SECONDARY OBJECTIVES:
- To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.
II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).
OUTLINE:
Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for radiation treatment with protons at University of Texas M. D. Anderson Cancer Center (UTMDACC)
Key inclusion criteria (2 listed)
- All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol
- Patients must sign a study-specific consent form prior to study entry
Key exclusion criteria (1 listed)
- Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete questionnaires | Other | Observational (questionnaire) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire) |
Primary outcome
Acute toxicities data in patients treated with proton therapy
Time frame: Up to 90 days after end of treatment
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. Upon analysis, the distribution of observed toxicity scores for each acute normal-tissue endpoint will be reported.
Late toxicities data in patients treated with proton therapy
Time frame: Starting 90 days or more after the end of radiotherapy
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade >= 2 late toxicity). The log-rank test will be used to compare event times in subgroups of patients with different dosimetric characteristics of treatment (e.g. portion of lung receiving > 20 Gy: <= 40% vs > 40%). In addition, normal-tissue complication probability models will be fitted to data corresponding to incidence of a late endpoint within a specified time frame, with analysis limited to patients having the specified follow-up (e.g. incidence of grade >= 2 late rectal bleeding within 2 years among patients followed for 2 years post-treatment).
Dose-response relationships for normal tissue toxicity after proton therapy
Time frame: Up to 3 months after therapy
Relevant dose-volume response models from the literature, such as the Lyman model, the parallel model, or the critical-element model will be fitted to the data when possible, and model parameter estimates reported. Confidence intervals for model parameter estimates will be derived using the profile-likelihood method.
1 secondary outcome
Symptom burden
Time frame: Up to 3 months after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 33198942Gjyshi O, Xu T, Elhammali A, Boyce-Fappiano D, Chun SG, Gandhi S, Lee P, Chen AB, Lin SH, Chang JY, Tsao A, Gay CM, Zhu XR, Zhang X, Heymach JV, Fossella FV, Lu C, Nguyen QN, Liao Z. Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC. J Thorac Oncol. 2021 Feb;16(2):269-277. doi: 10.1016/j.jtho.2020.10.013. Epub 2020 Oct 22.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven J Frank principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Esophageal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven J. Frank (713-563-2300, sjfrank@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicities data in patients treated with proton therapy (time frame: Up to 90 days after end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.