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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00043975 | Other Identifier | University of Michigan IRBMED |
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To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.
Published data demonstrate equal efficacy and improved quality of life when platinum and a taxane were compared with platinum and 5-Fluorouracil [31]. Additionally, weekly cisplatin regimens (30-40 mg/m2) with radiotherapy appear to be equally efficacious and better tolerated than standard high-dose cisplatin (100 mg/ m2) regimens with radiation therapy for locally advanced SCCHN [32] The investigators will thus attempt to reduce toxicity from induction chemotherapy with the use of docetaxel/cisplatin (or carboplatin) (TP) in place of our previously used standard regimen of cisplatin and 5-fluorouracil (PF) and administer weekly cisplatin (or carboplatin) with radiation for those patients who are responders to induction therapy. Finally, Phase I/II testing of the small molecule inhibitor, AT-101, has recently been completed, and suggests activity in solid tumors when combined with cytotoxic agents. Since the investigators have achieved such high survival rates with our treatment selection approach in laryngeal cancer, our ultimate goal is to reduce the rate of salvage laryngectomy which should improve quality of life. The investigators hypothesize that specific inhibition of Bcl-2/Bcl-xL function can increase response rates to neoadjuvant chemotherapy and decrease the need for salvage laryngectomy. Hence, the investigators propose this study: the treatment of patients with advanced SCC of the larynx with one cycle of platinum plus docetaxel with AT-101, followed by chemoradiotherapy for those responding to this induction regimen and reserving total laryngectomy for those who are non-responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platinum/docetaxel + AT-101 | Experimental | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. |
|
| Active Comparator arm | Active Comparator | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-101 | Drug | Patients will receive AT-101 40 mg orally two times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy | Up to 3 months after end of treatment |
| Progression-free Survival | Time from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method. | Up to 3 years after randomization |
| Overall Response Rate (ORR) | ORR (Complete Response [CR] plus Partial Response [PR]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer. | Up to approximately 60 days |
| Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3. | Up to 3 years after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Head and Neck Related Quality of Life (QOL) | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. | Up to 28 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Swiecicki, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
one subject was enrolled; however, disease progression was discovered before active treatment and therefore the patient never was treated with study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Platinum/Docetaxal + AT-101 | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients will receive AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
| FG001 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platinum/Docetaxal + AT-101 | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients will receive AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg Per physician discretion, carboplatin was used in lieu of cisplatin for 13 patients in this arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy | Posted | Count of Participants | Participants | Up to 3 months after end of treatment |
|
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platinum/Docetaxal + AT-101 | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients received AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Swiecicki | University of Michigan Rogel Cancer Center | 734-647-1017 | pswiecic@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2018 | May 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2018 | May 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C028178 | gossypol acetic acid |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Docetaxel (Taxotere) 75 mg/m2 |
|
|
| Cisplatin | Drug | Cisplatin 100 mg/m2 |
|
| Carboplatin | Drug | Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
|
| Voice Related QOL | The University of Michigan Voice Related Quality of Life Measure (V-RQOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-50 (10 items scale 1-5) with high scores indicating a worse outcome. | Up to 28 months post treatment |
| Functional Assessment QOL | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. EATING Domain is reported here as a functional assessment. | Up to 28 months post treatment |
| BG001 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Per physician discretion, carboplatin was used in lieu of cisplatin for 10 patients in this arm Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg |
|
|
| Primary | Progression-free Survival | Time from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years after randomization |
|
|
|
| Primary | Overall Response Rate (ORR) | ORR (Complete Response [CR] plus Partial Response [PR]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer. | This outcome measure only applies to those subjects treated with induction chemotherapy with platinum and docetaxel plus AT-101 and therefore only one arm is being reported | Posted | Count of Participants | Participants | Up to approximately 60 days |
|
|
|
| Primary | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3. | Posted | Number | percentage of Patients | Up to 3 years after end of treatment |
|
|
|
| Secondary | Head and Neck Related Quality of Life (QOL) | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. | Number of participants analyzed varies below based on completion compliance | Posted | Median | Inter-Quartile Range | units on a scale | Up to 28 months post treatment |
|
|
|
| Secondary | Voice Related QOL | The University of Michigan Voice Related Quality of Life Measure (V-RQOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-50 (10 items scale 1-5) with high scores indicating a worse outcome. | number of participants analyzed varies due to patient compliance and patients coming off trial per protocol | Posted | Median | Inter-Quartile Range | score on a scale | Up to 28 months post treatment |
|
|
|
| Secondary | Functional Assessment QOL | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. EATING Domain is reported here as a functional assessment. | Number of participants analyzed varies below based on completion compliance | Posted | Median | Inter-Quartile Range | score on a scale | Up to 28 months post treatment |
|
|
|
| 1 |
| 36 |
| 14 |
| 36 |
| 36 |
| 36 |
| EG001 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg | 1 | 18 | 5 | 18 | 18 | 18 |
| Allergic reaction | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Disease Progression | General disorders | CTCAE (3.0) | Non-systematic Assessment | Cause of death larynx cancer. |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Squamous Cell Carcinoma - Nose | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Acute Kidney injury | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection, Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection, Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection, Upper airway NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Intracranial hemorrhage | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neck pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| pulmonary embolism | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tracheal hemorrhage | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Acne | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constitutional Symptoms - Other (Specify) | General disorders | CTCAE (3.0) | Non-systematic Assessment | BUN Increase |
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| Constitutional Symptoms - Other (Specify) | General disorders | CTCAE (3.0) | Non-systematic Assessment | restless leg syndrome |
|
| Constitutional Symptoms - Other (Specify) | General disorders | CTCAE (3.0) | Non-systematic Assessment | paronychia of left thumb |
|
| Constitutional Symptoms - Other (Specify) | General disorders | CTCAE (3.0) | Non-systematic Assessment | increase mucus in throat |
|
| Constitutional Symptoms - Other (Specify) | General disorders | CTCAE (3.0) | Non-systematic Assessment | orthostatic |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dermal change | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | skin changes |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | cut on the right hand |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | psoriasis flare up on lower right and left arms |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | psoriasis flare up on abdomen |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | drainage from neck incisions |
|
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | hydration infusion site swelling |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ear, nose and throat examination abnormal | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema: head and neck | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema: viscera | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Erythema multiforme | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Esophageal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Flu-like syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fracture | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| GI - Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | hametochezia |
|
| GI - Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | indigestion |
|
| GI - Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | increase reflux symptoms |
|
| Hand-and-foot syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hearing (without monitoring program) | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Heartburn | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemoglobin decrease | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemorrhage - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment | hemoptysis |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypercalcemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypocalcemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection - Other (Specify) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | thrush |
|
| Infection - Other (Specify) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | pneumonia |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Intraoperative ocular injury | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Involuntary movement | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Joint pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Laryngoscopy abnormal | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Musculoskeletal - Other (Specify) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment | muscle twitching |
|
| Musculoskeletal - Other (Specify) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment | DHT discomfort |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| neutropenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Nystagmus | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Personality change | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Radiation recall reaction (dermatologic) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Sinus bradycardia | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Taste alteration | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Toothache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tracheostomy site bleeding | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Trigeminal nerve disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tumor pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Upper aerodigestive tract infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Voice alteration | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| Emotion- 6 months |
|
|
| Emotion- 12 months |
|
|
| Emotion- 24 months |
|
|
| Speech- Prior to treatment |
|
|
| Speech- 6 Months |
|
|
| Speech- 12 Months |
|
|
| Speech- 24 Months |
|
|
| Pain- Prior to treatment |
|
|
| Pain- 6 months |
|
|
| Pain- 12 months |
|
|
| Pain- 24 months |
|
|
| VRQOL-SUM- 6 Months |
|
|
| VRQOL-SUM- 12 Months |
|
|
| VRQOL-SUM- 24 Months |
|
|
| NOISY_VAL_- Prior to treatment |
|
|
| NOISY_VAL_- 6months |
|
|
| NOISY_VAL_- 12 months |
|
|
| NOISY_VAL_- 24 months |
|
|
| OUTOFAIR_VAL- Prior to treatment |
|
|
| OUTOFAIR_VAL- 6 months |
|
|
| OUTOFAIR_VAL- 12 months |
|
|
| OUTOFAIR_VAL- 24 months |
|
|
| WHATCOMEOUT_VAL_3n- Prior to treatment |
|
|
| WHATCOMEOUT_VAL_3n- 6 months |
|
|
| WHATCOMEOUT_VAL_3n- 12 months |
|
|
| WHATCOMEOUT_VAL_3n- 24 months |
|
|
| ANXIOUS_VAL_4n- Prior to treatment |
|
|
| ANXIOUS_VAL_4n- 6 months |
|
|
| ANXIOUS_VAL_4n- 12 months |
|
|
| ANXIOUS_VAL_4n- 24 months |
|
|
| DEPRESSED_VAL_5n- Prior to treatment |
|
|
| DEPRESSED_VAL_5n- 6 months |
|
|
| DEPRESSED_VAL_5n- 12 months |
|
|
| DEPRESSED_VAL_5n- 24 months |
|
|
| TROUBLEPHONE_VAL_6n- Prior to treatment |
|
|
| TROUBLEPHONE_VAL_6n- 6 Months |
|
|
| TROUBLEPHONE_VAL_6n- 12 Months |
|
|
| TROUBLEPHONE_VAL_6n- 24 Months |
|
|
| TROUBLEJOB_VAL_7n- Prior to treatment |
|
|
| TROUBLEJOB_VAL_7n- 6 Months |
|
|
| TROUBLEJOB_VAL_7n- 12 Months |
|
|
| TROUBLEJOB_VAL_7n- 24 Months |
|
|
| AVOIDSOCIALLY_VAL_8n- Prior to treatment |
|
|
| AVOIDSOCIALLY_VAL_8n- 6 months |
|
|
| AVOIDSOCIALLY_VAL_8n- 12 months |
|
|
| AVOIDSOCIALLY_VAL_8n- 24 months |
|
|
| REPEATMYSELF_VAL_9n- Prior to treatment |
|
|
| REPEATMYSELF_VAL_9n- 6 months |
|
|
| REPEATMYSELF_VAL_9n- 12 months |
|
|
| REPEATMYSELF_VAL_9n- 24 months |
|
|
| LESSOUTGOING_VAL_10n- Prior to treatment |
|
|
| LESSOUTGOING_VAL_10n- 6 months |
|
|
| LESSOUTGOING_VAL_10n- 12 months |
|
|
| LESSOUTGOING_VAL_10n- 24 months |
|
|
| EATING- 6 months |
|
|
| EATING- 12 months |
|
|
| EATING- 24 months |
|
|