De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
Study Details
Study Description
Brief Summary
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality of life and patient reported outcomes will be obtained prior to, during, and after CRT.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: De-escalated Radiation and Chemotherapy Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. |
Radiation: Intensity Modulated Radiotherapy (IMRT)
All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease).
Drug: Cisplatin
Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory.
Other Names:
Procedure: Limited surgical evaluation
4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT.
|
Outcome Measures
Primary Outcome Measures
- Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). [6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened]
Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
Secondary Outcome Measures
- Two-Year Local Control [Median follow-up was 36 months with a range of 5-53 months]
Local control is the arrest of cancer growth at the site of origin.
- Regional Control [Median follow-up was 36 months with a range of 5-53 months]
Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.
- Cause-Specific Survival [The median follow-up was 36 months with a range of 5-53 months]
Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.
- Distant Metastases Free Survival [the median follow-up was 36 months with a range of]
Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.
- Overall Survival Rate [Median follow-up was 36 months with a range of 5-53 months.]
The percentage of participants who are still alive from the start of treatment.
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 [Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT]
The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL [Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT]
The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
- The Eating Assessment Tool (EAT-10) Composite Score [Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT]
The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.
- The Rosenbek Penetration Aspiration Scale [Prior to CRT and 4-8 weeks after completion of CRT]
The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 18 years of age
-
T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
-
Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
-
≤ 10 pack-years smoking history or > 5 years of abstinence from smoking
-
History/physical examination within 8 weeks prior to registration
-
Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration.
-
The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
-
Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.
-
Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN.
-
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
-
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
-
Patients must be deemed able to comply with the treatment plan and follow-up schedule.
-
Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
-
Prior history of radiation therapy to the head and neck
-
Prior history of head and neck cancer.
-
Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol; Pre-existing ≥ grade 2 neuropathy; Prior organ transplant.
-
Known HIV positive
-
Significant pre-existing hearing loss, as defined by the patient or treating physician.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penrose Cancer Center | Colorado Springs | Colorado | United States | 80907 |
| 2 | University of Florida, Department of Radiation Oncology | Gainesville | Florida | United States | 32610-0385 |
| 3 | University of North Carolina at Chapel Hill, Department of Radiation Oncology | Chapel Hill | North Carolina | United States | 27599 |
| 4 | Rex Healthcare | Raleigh | North Carolina | United States | 27607 |
| 5 | Rex Cancer Center of Wakefield | Raleigh | North Carolina | United States | 27614 |
Sponsors and Collaborators
- UNC Lineberger Comprehensive Cancer Center
Investigators
- Principal Investigator: Bhishamjit Chera, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- LCCC 1120
Study Results
Participant Flow
| Recruitment Details | Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC). |
|---|---|
| Pre-assignment Detail | Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable. |
| Arm/Group Title | Single Intervention |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Period Title: Overall Study | |
| STARTED | 45 |
| COMPLETED | 43 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | De-escalated Radiation and Chemotherapy |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Overall Participants | 44 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
61
|
| Sex: Female, Male (Count of Participants) | |
| Female |
39
88.6%
|
| Male |
5
11.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
9.1%
|
| White |
40
90.9%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
44
100%
|
| Marital Status (Count of Participants) | |
| Married |
34
77.3%
|
| Unmarried |
10
22.7%
|
| Tobacco Use (Count of Participants) | |
| Never Smoker |
36
81.8%
|
| <=10 Pack Years |
6
13.6%
|
| > 10 Pack Years |
2
4.5%
|
| Primary Tumor Location (Count of Participants) | |
| Tonsil |
16
36.4%
|
| Base of Tongue |
26
59.1%
|
| Unknown Primary |
2
4.5%
|
| T Stage (Count of Participants) | |
| T0 |
2
4.5%
|
| T1 |
13
29.5%
|
| T2 |
22
50%
|
| T3 |
7
15.9%
|
| N Stage (Count of Participants) | |
| N0 |
4
9.1%
|
| N1 |
10
22.7%
|
| N2a |
2
4.5%
|
| N2b |
21
47.7%
|
| N2c |
7
15.9%
|
| HPV/p16 Status (Count of Participants) | |
| HPV+/p16+ |
28
63.6%
|
| HPV-/p16+ |
16
36.4%
|
Outcome Measures
| Title | Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). |
|---|---|
| Description | Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens. |
| Time Frame | 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened |
Outcome Measure Data
| Analysis Population Description |
|---|
| Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated. |
| Arm/Group Title | De-escalated Radiation and Chemotherapy |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 43 |
| Count of Participants [Participants] |
37
84.1%
|
| Title | Two-Year Local Control |
|---|---|
| Description | Local control is the arrest of cancer growth at the site of origin. |
| Time Frame | Median follow-up was 36 months with a range of 5-53 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | De-escalated Radiation and Chemotherapy |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 44 |
| Number [percentage of participants] |
100
227.3%
|
| Title | Regional Control |
|---|---|
| Description | Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin. |
| Time Frame | Median follow-up was 36 months with a range of 5-53 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Intervention |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 44 |
| Number [percentage of participants] |
100
227.3%
|
| Title | Cause-Specific Survival |
|---|---|
| Description | Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC. |
| Time Frame | The median follow-up was 36 months with a range of 5-53 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Intervention |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 44 |
| Number [percentage of participants] |
100
227.3%
|
| Title | Distant Metastases Free Survival |
|---|---|
| Description | Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread. |
| Time Frame | the median follow-up was 36 months with a range of |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Intervention |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 44 |
| Number [percentage of participants] |
100
227.3%
|
| Title | Overall Survival Rate |
|---|---|
| Description | The percentage of participants who are still alive from the start of treatment. |
| Time Frame | Median follow-up was 36 months with a range of 5-53 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Intervention |
|---|---|
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
| Measure Participants | 44 |
| Number [percentage of participants] |
95
215.9%
|
| Title | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 |
|---|---|
| Description | The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). |
| Time Frame | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Baseline | 6-8 Weeks Post-Treatment | Post-Surgery |
|---|---|---|---|
| Arm/Group Description | This data was collected pre-chemoradiotherapy treatment. | This data was collected 6-8 weeks post-chemoradiotherapy. | This data was collected at the first follow-up post-surgery. |
| Measure Participants | 44 | 42 | 42 |
| Pain |
19
|
25
|
26
|
| Swallowing |
11
|
19
|
18
|
| Senses Problems |
5
|
35
|
28
|
| Speech Problems |
10
|
13
|
16
|
| Trouble with Social Eating |
8
|
29
|
24
|
| Trouble with Social Contact |
5
|
15
|
8
|
| Less Sexuality |
13
|
34
|
23
|
| Teeth |
3
|
10
|
12
|
| Opening Mouth |
5
|
15
|
18
|
| Dry Mouth |
16
|
69
|
64
|
| Sticky Saliva |
6
|
61
|
49
|
| Cough |
17
|
25
|
22
|
| Felt Ill |
8
|
20
|
11
|
| Pain Killers |
34
|
43
|
33
|
| Nutritional Supplements |
39
|
55
|
40
|
| Feeding Tube |
0
|
40
|
17
|
| Weight Loss |
20
|
38
|
36
|
| Weight Gain |
25
|
40
|
10
|
| Title | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL |
|---|---|
| Description | The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms. |
| Time Frame | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Baseline | 6-8 Weeks Post-Treatment | Post-Surgery |
|---|---|---|---|
| Arm/Group Description | This data was collected pre-chemoradiotherapy treatment. | This data was collected 6-8 weeks post-chemoradiotherapy. | This data was collected at the first follow-up post-surgery. |
| Measure Participants | 44 | 42 | 42 |
| Global health status/QoL |
80
|
61
|
69
|
| Physical functioning |
96
|
78
|
85
|
| Role functioning |
96
|
65
|
77
|
| Emotional functioning |
77
|
77
|
84
|
| Cognitive functioning |
91
|
86
|
87
|
| Social functioning |
88
|
66
|
81
|
| Fatigue |
20
|
42
|
31
|
| Nausea and vomiting |
2
|
13
|
4
|
| Pain |
15
|
21
|
20
|
| Dyspnea |
5
|
11
|
6
|
| Insomnia |
23
|
34
|
23
|
| Appetite loss |
14
|
40
|
33
|
| Constipation |
12
|
17
|
16
|
| Diarrhea |
5
|
4
|
6
|
| Financial difficulties |
16
|
28
|
22
|
| Title | The Eating Assessment Tool (EAT-10) Composite Score |
|---|---|
| Description | The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40. |
| Time Frame | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Baseline | 6-8 Weeks Post-Treatment | Post-Surgery |
|---|---|---|---|
| Arm/Group Description | This data was collected pre-chemoradiotherapy treatment. | This data was collected 6-8 weeks post-chemoradiotherapy. | This data was collected at the first follow-up post surgery. |
| Measure Participants | 43 | 41 | 42 |
| Mean (95% Confidence Interval) [units on a scale] |
4
|
13
|
11
|
| Title | The Rosenbek Penetration Aspiration Scale |
|---|---|
| Description | The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject. |
| Time Frame | Prior to CRT and 4-8 weeks after completion of CRT |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pre-treatment | Post-treatment |
|---|---|---|
| Arm/Group Description | This data was collected before the treatment. | This data was collected 4-8 weeks after chemoradiation therapy |
| Measure Participants | 37 | 31 |
| Thin Substances |
1.30
(.62)
|
1.90
(1.83)
|
| Pureed Substances |
1.03
(0.16)
|
1.19
(0.54)
|
| Solid Substances |
1.03
(0.16)
|
1.03
(0.19)
|
Adverse Events
| Time Frame | 4 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Intervention | |
| Arm/Group Description | Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively | |
All Cause Mortality |
||
| Single Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/45 (2.2%) | |
Serious Adverse Events |
||
| Single Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | 15/45 (33.3%) | |
| Blood and lymphatic system disorders | ||
| Blood and lymphatic system disorders - Other, specify | 1/45 (2.2%) | |
| Blood and lymphatic system disorders - Other, specify | 1/45 (2.2%) | |
| Febrile neutropenia | 1/45 (2.2%) | |
| Gastrointestinal disorders | ||
| Constipation | 1/45 (2.2%) | |
| Diarrhea | 1/45 (2.2%) | |
| Nausea | 1/45 (2.2%) | |
| Vomiting | 2/45 (4.4%) | |
| General disorders | ||
| Fever | 1/45 (2.2%) | |
| Infections and infestations | ||
| Sepsis | 1/45 (2.2%) | |
| Urinary tract infection | 1/45 (2.2%) | |
| Soft tissue infection | 1/45 (2.2%) | |
| Investigations | ||
| Alanine aminotransferase increased | 1/45 (2.2%) | |
| Aspartate aminotransferase increased | 1/45 (2.2%) | |
| Metabolism and nutrition disorders | ||
| Dehydration | 2/45 (4.4%) | |
| Hyponatremia | 1/45 (2.2%) | |
| Anorexia | 1/45 (2.2%) | |
| Nervous system disorders | ||
| Stroke | 1/45 (2.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Aspiration | 2/45 (4.4%) | |
| Vascular disorders | ||
| Hematoma | 1/45 (2.2%) | |
| Hypotension | 1/45 (2.2%) | |
Other (Not Including Serious) Adverse Events |
||
| Single Intervention | ||
| Affected / at Risk (%) | # Events | |
| Total | 40/45 (88.9%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 3/45 (6.7%) | |
| Ear and labyrinth disorders | ||
| Middle ear inflammation | 1/45 (2.2%) | |
| Tinnitus | 16/45 (35.6%) | |
| Endocrine disorders | ||
| Hypothyroidism | 2/45 (4.4%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/45 (2.2%) | |
| Constipation | 2/45 (4.4%) | |
| Dry mouth | 32/45 (71.1%) | |
| Dysphagia | 32/45 (71.1%) | |
| Esophageal pain | 1/45 (2.2%) | |
| Esophageal stenosis | 1/45 (2.2%) | |
| Mucositis oral | 34/45 (75.6%) | |
| Nausea | 28/45 (62.2%) | |
| Vomiting | 18/45 (40%) | |
| Diarrea | 1/45 (2.2%) | |
| General disorders | ||
| Fatigue | 32/45 (71.1%) | |
| Fever | 1/45 (2.2%) | |
| Infusion site extravasation | 1/45 (2.2%) | |
| Neck edema | 29/45 (64.4%) | |
| Pain | 34/45 (75.6%) | |
| Immune system disorders | ||
| Allergic reaction | 1/45 (2.2%) | |
| Infections and infestations | ||
| Mucosal infection | 1/45 (2.2%) | |
| Salivary gland infection | 1/45 (2.2%) | |
| Sinusitis | 1/45 (2.2%) | |
| Soft tissue infection | 2/45 (4.4%) | |
| Upper respiratory infection | 1/45 (2.2%) | |
| Infections and infestations - Other, specify | 1/45 (2.2%) | |
| Injury, poisoning and procedural complications | ||
| Dermatitis radiation | 32/45 (71.1%) | |
| Investigations | ||
| Alanine aminotransferase increased | 1/45 (2.2%) | |
| Neutrophil count decreased | 1/45 (2.2%) | |
| Platelet count decreased | 2/45 (4.4%) | |
| Weight loss | 4/45 (8.9%) | |
| White blood cell decreased | 1/45 (2.2%) | |
| Lymphopenia | 1/45 (2.2%) | |
| Metabolism and nutrition disorders | ||
| Anorexia | 31/45 (68.9%) | |
| Dehydration | 5/45 (11.1%) | |
| Hyperglycemia | 1/45 (2.2%) | |
| Hypoalbuminemia | 1/45 (2.2%) | |
| Hyponatremia | 3/45 (6.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Osteonecrosis of jaw | 2/45 (4.4%) | |
| Trismus | 1/45 (2.2%) | |
| Nervous system disorders | ||
| Dysgeusia | 32/45 (71.1%) | |
| Syncope | 2/45 (4.4%) | |
| Vagus nerve disorder | 1/45 (2.2%) | |
| Psychiatric disorders | ||
| Anxiety | 19/45 (42.2%) | |
| Depression | 14/45 (31.1%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 3/45 (6.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Hoarseness | 7/45 (15.6%) | |
| Nasal congestion | 1/45 (2.2%) | |
| Pharyngeal mucositis | 31/45 (68.9%) | |
| Voice alteration | 11/45 (24.4%) | |
| Respiratory, thoracic and mediastinal disorders - Other, specify | 1/45 (2.2%) | |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 29/45 (64.4%) | |
| Rash acneiform | 1/45 (2.2%) | |
| Surgical and medical procedures | ||
| Surgical and medical procedures - Other, specify | 4/45 (8.9%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Robin V. Johnson |
|---|---|
| Organization | UNC Lineberger Comprehensive Cancer Center |
| Phone | 919-966-1125 |
| Robin_V_Johnson@med.unc.edu |
- LCCC 1120