Trial · NCT00599131
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
NCT00599131, Phase 2, Terminated, University of Michigan Rogel Cancer Center; results first posted 2014-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE). Trials, record NCT00599131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00599131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
- NCT number
- NCT00599131
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Cancer of Larynx
- Interventions
- Cisplatin, Cetuximab, 5-Fluorouracil, Docetaxel
- First posted
- 2008-01-23
- Last updated
- 2015-12-03
- Results first posted
- 2014-06-16
- Limitations and caveats
- The study was discontinued prematurely due to an early stopping rule.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving Histologic Complete Response | 3 years | The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy. |
| Secondary | The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF. | Day 23 | To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies. |
| Secondary | The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment. | 24 months | To evaluate the quality of life (QOL). |
| Secondary | Overall Survival Time | 3 years | To determine the overall survival rates compared to the overall survival rates of historical controls. |
| Secondary | The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia | 3 years. | To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving Histologic Complete Response | 3 years | The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited. | ||
| SECONDARY | The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF. | Day 23 | The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited. | ||
| SECONDARY | The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment. | 24 months | The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited. | ||
| SECONDARY | Overall Survival Time | 3 years | The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited. | ||
| SECONDARY | The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia | 3 years. | The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy/Radiation/Surgery | 4 | |
| Overall Study | COMPLETED | Chemotherapy/Radiation/Surgery | 4 | |
| Overall Study | NOT COMPLETED | Chemotherapy/Radiation/Surgery | 0 |
Source ClinicalTrials.gov
Adverse events59
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 | Tinnitus | Ear and labyrinth disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 1 |
| other | Neutrophils/granulocytes | Blood and lymphatic system disorders | Chemotherapy/Radiation/Surgery | 2 | 4 | 2 |
| other | Fatigue | General disorders | Chemotherapy/Radiation/Surgery | 2 | 4 | 3 |
| other | Insomnia | Psychiatric disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 2 |
| other | Weight loss | General disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 1 |
| other | Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 1 |
| other | Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | Chemotherapy/Radiation/Surgery | 3 | 4 | 3 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Chemotherapy/Radiation/Surgery | 1 | 4 | 1 |
| other | Rash: dermatitis associated with radiation | Skin and subcutaneous tissue disorders | Chemotherapy/Radiation/Surgery | 4 | 4 | 4 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy/Radiation/Surgery | ||
| Total, other adverse events | Chemotherapy/Radiation/Surgery | 4 | 4 |
| Total, serious adverse events | Chemotherapy/Radiation/Surgery | 2 | 4 |
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/NCT00599131
GET https://conductscience.org/api/trials/v1/NCT00599131/events?page=2