Trial · NCT00566540
Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
NCT00566540, Phase 2, Terminated, Ohio State University Comprehensive Cancer Center; results first posted 2021-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer. Trials, record NCT00566540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00566540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
- NCT number
- NCT00566540
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Conditions
- Head and Neck Cancer
- Interventions
- Cisplatin, Paclitaxel, Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation, Triple endoscopy and biopsy
- First posted
- 2007-12-03
- Last updated
- 2021-11-26
- Results first posted
- 2021-11-26
- Limitations and caveats
- The study was stopped in the early stages and no data analysis was completed and results produced.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Treatment | Up to one year | Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy |
| Secondary | Disease-free Interval and Failure Sites | Up to one year | Assess disease-free interval and failure sites of a new treatment regimen. |
| Secondary | Correlation of Quality of Life With Treatment Outcome | Up to one year | Assess quality of life with treatment outcome will be obtained at baseline (prior to treatment) and at 6 months post treatment and one year post-treatment follow-ups. |
| Secondary | Percentage of Participants With Serious Adverse Events | Up to one year | Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen. |
| Secondary | Treatment Completion | up to one year | Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year. |
| Other | Correlation of Molecular Markers With Treatment Outcome | Up to week 14 | Evaluate potential correlative molecular markers with treatment outcome |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Treatment | Up to one year | The data was not collected or analyzed due to discontinuation of study in early stages. | ||
| SECONDARY | Disease-free Interval and Failure Sites | Up to one year | The data was not collected or analyzed due to discontinuation of study in early stages. | ||
| SECONDARY | Correlation of Quality of Life With Treatment Outcome | Up to one year | The data analysis was unable to be completed due to discontinuation of study in early stages | ||
| SECONDARY | Percentage of Participants With Serious Adverse Events | Up to one year | percentage of patients | NUMBER | |
| SECONDARY | Treatment Completion | up to one year | The data analysis was unable to be completed due to discontinuation of study in early stages | patients | NUMBER |
| OTHER_PRE_SPECIFIED | Correlation of Molecular Markers With Treatment Outcome | Up to week 14 | The data was not collected or analyzed due to discontinuation of study in early stages. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Leukocytes | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Rash | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Colitis | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Dehydration | 18 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Diarrhea | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Vomiting | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Hemorrhage, Upper Respiratory | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Infection with normal ANC | 9 | percentage of patients | |
| Percentage of Participants With Serious Adverse Events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | Edema | 9 | percentage of patients | |
| Treatment Completion | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 7 | patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 11 | |
| Overall Study | COMPLETED | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 11 | |
| Overall Study | NOT COMPLETED | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 0 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Extremity pain | Musculoskeletal and connective tissue disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 6 | 11 | 6 |
| other | Edema-limb | General disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 4 | 11 | 4 |
| other | Oral cavity pain | Gastrointestinal disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 10 | 11 | 10 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 4 | 11 | 4 |
| other | Salivary gland changes | Gastrointestinal disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 4 | 11 | 4 |
| other | Mucositis/stomatitis | Gastrointestinal disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 10 | 11 | 10 |
| other | Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 4 | 11 | 4 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 6 | 11 | 6 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 3 | 11 | 3 |
| other | Fatigue | General disorders | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 10 | 11 | 10 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 2 | 11 |
| Total, other adverse events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 11 | 11 |
| Total, serious adverse events | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | 11 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00566540
GET https://conductscience.org/api/trials/v1/NCT00566540/events?page=2