Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01893307 |
|
Recruitment Status :
Recruiting
First Posted : July 9, 2013
Last Update Posted : May 16, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Radiation: Photon Beam Radiation Therapy Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment | Phase 2 Phase 3 |
PRIMARY OBJECTIVES:
I. To compare the rates and severity of late grade 3-5 toxicity between intensity-modulated photon therapy (IMRT) and intensity-modulated proton therapy (IMPT) following the treatment of oropharyngeal tumors. (Phase II) II. To compare the rate of 3-year progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors. (Phase III)
SECONDARY OBJECTIVES:
I. Disease-related outcomes (2-year progression-free survival, patterns of failure, 2-year overall survival, 2-year [yr] distant metastasis free survival, and second primary cancers). (Phase III) II. Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), Xerostomia and Health Questionnaire (European Quality of Life 5-Dimension three level scale [EQ-5D-3L]), work status (Work Productivity and Activity Impairment: Specific Health Problem [WPAI: SHP]). (Phase III) III. Physician reported toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0. (Phase III) IV. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. (Phase III) V. Cost-benefit economic analysis of treatment. (Phase III) VI. To determine whether specific molecular profiles are associated with overall or progression-free survival. (Phase III) VII. To investigate associations between changes in serum biomarkers or human papillomavirus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. (Phase III) VIII. To bank peripheral blood at time of enrollment, weeks 2, 4, and 6 during treatment and during follow up visits for 2 years to explore the ability of circulating markers to predict outcome. (Phase III) IX. To bank head and neck tissues to explore the ability of tissue-based markers to predict outcome. (Phase III) X. To bank peripheral blood and tissues for future interrogations. (Phase III) XI. Acute side effects of radiation therapy will be assessed. (Phase III)
EXPLORATORY OBJECTIVE:
I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but were denied insurance coverage for the treatment arm she/he was randomized to; or may have dropped out of the study for other reasons after being randomized. These patients will compromise Group 3: consisting of patients randomized to Protons but not treated and Group 4: consisting of patients randomized to IMRT but not treated at the designated institution. Furthermore, these patients will only be followed for recurrence and survival.(Phase III)
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo IMRT once daily (QD) five days a week for approximately 6.5 weeks.
ARM II: Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck |
| Actual Study Start Date : | August 26, 2013 |
| Estimated Primary Completion Date : | August 31, 2025 |
| Estimated Study Completion Date : | August 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm I (IMRT)
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
|
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Radiation: Photon Beam Radiation Therapy Undergo IMRT
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
|
Experimental: Arm II (IMPT)
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
|
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMPT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Radiation: Proton Beam Radiation Therapy Undergo IMPT
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
- Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II) [ Time Frame: Up to 2 years ]Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., human papillomavirus (HPV)/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.
- Cumulative incidence of acute grade 3+ toxicity (Phase II) [ Time Frame: Up to 2 years ]Will be graded according to the NCI CTCAE version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., HPV/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.
- Overall survival (OS) (Phase II) [ Time Frame: Up to 5 years ]Stratified by treatment arm and estimated using the product limit estimator of Kaplan and Meier. Cox proportional hazards regression will be used to model OS as a function of potential prognostic factors. Hazard ratios for the prognostic factors from this model will be estimated with 95% confidence intervals.
- Overall survival (Phase III) [ Time Frame: Up to 5 years ]Will be summarized at critical time points using the method of Kaplan-Meier. Kaplan-Meier plots will be used to visualize the time-to-event information by treatment arm, and the trial will be monitored based on results from log-rank tests used to compare treatment arms. Furthermore, Cox proportional hazards regression will be used to assess the time-to-event outcomes while adjusting for covariates of interest.
- Progression-free survival (Phase III) [ Time Frame: Up to 3 years ]Will be summarized at critical time points using the method of Kaplan-Meier. Kaplan-Meier plots will be used to visualize the time-to-event information by treatment arm, and the trial will be monitored based on results from log-rank tests used to compare treatment arms. Furthermore, Cox proportional hazards regression will be used to assess the time-to-event outcomes while adjusting for covariates of interest.
- Quality of life (QoL) (Phase II and III) [ Time Frame: Up to 5 years ]QoL assessments will be summarized using the mean score and standard deviation for each time point of interest. Mean response trajectories will be plotted over the time horizon for each QoL instrument administered to patients in order to explore differences between treatment arms along with other patient characteristics of interest. Other analyses such as area under the curve and linear mixed models will be used to make statistical comparisons between treatment arms while adjusting for covariates of interest.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer [AJCC] version [v]7 stage III-IV A,B)
- Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
- Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1, or 2
- Negative pregnancy test for women of child bearing potential
- Concurrent chemotherapy
- Bilateral neck radiation
Exclusion Criteria:
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- Pregnant or breast-feeding females
-
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- Myocardial infarction within 3 months of registration
- Distant metastases (stage IV C, any T, any N and M1)
- Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893307
Show 22 study locations
| Principal Investigator: | Steven J Frank | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01893307 |
| Other Study ID Numbers: |
2012-0825 NCI-2013-01879 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2012-0825 ( Other Identifier: M D Anderson Cancer Center ) R03CA188162 ( U.S. NIH Grant/Contract ) R56DE025248 ( U.S. NIH Grant/Contract ) U19CA021239 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 9, 2013 Key Record Dates |
| Last Update Posted: | May 16, 2022 |
| Last Verified: | May 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Carcinoma Carcinoma, Squamous Cell Oropharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |