Trial · NCT01711658
TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
NCT01711658, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2021-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. Trials, record NCT01711658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01711658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
- NCT number
- NCT01711658
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Non-HPV Locally Advanced Head and Neck Cancer
- Interventions
- IMRT, Cisplatin, placebo, Lapatinib
- First posted
- 2012-10-22
- Last updated
- 2023-10-17
- Results first posted
- 2021-11-29
- Limitations and caveats
A total of 69 progression-free survival (PFS) were required. As of September 13, 2020, the number of observed PFS events was 66. At the Radiation Therapy Oncology Group Foundation Data Monitoring Committee meeting on October 22, 2020, a decision was made to report the final results using data through November 30, 2020. This decision has a minor impact (\<1%) on the power given that 67 PFS events are included in the final analysis of this trial.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive Without Progression (Progression-free Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported. |
| Secondary | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | An event for overall survival is death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. |
| Secondary | Percentage of Participants With Distant Metastases | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. |
| Secondary | Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment. |
| Secondary | Percentage of Participants Who Complied With Protocol Treatment | From start of treatment to end of treatment (approximately 5 months from randomization). | Compliance with protocol treatment is defined as "per protocol" or "acceptable variation" per study chair review for IMRT, cisplatin, pre-IMRT lapatinib/placebo, concurrent lapatinib/placebo, and maintenance lapatinib/placebo. Rates of treatment compliance were compared between groups by a 2-sided Fisher's exact test. |
| Secondary | Percentage of Participants With Local-regional Progression | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | Failure for local-regional control endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Failure rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. |
| Secondary | Performance Status Scale for Head & Neck Cancer. | 3 months, 1 year, and 2 years | |
| Secondary | Functional Assessment of Cancer Therapy - Head & Neck. | 3 months, 1 year, and 2 years. | |
| Secondary | University of Michigan Xerostomia-Related Quality of Life Scale. | 3 months, 1 year, and 2 years. | |
| Secondary | HER2, EGFR, EMT as Biomarkers of Response. | End of Study |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Alive Without Progression (Progression-free Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Distant Metastases | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | Participants Who Started Protocol Treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Complied With Protocol Treatment | From start of treatment to end of treatment (approximately 5 months from randomization). | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local-regional Progression | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Performance Status Scale for Head & Neck Cancer. | 3 months, 1 year, and 2 years | |||
| SECONDARY | Functional Assessment of Cancer Therapy - Head & Neck. | 3 months, 1 year, and 2 years. | |||
| SECONDARY | University of Michigan Xerostomia-Related Quality of Life Scale. | 3 months, 1 year, and 2 years. | |||
| SECONDARY | HER2, EGFR, EMT as Biomarkers of Response. | End of Study | No assays were performed, and no data were collected for this outcome measure. Specimen use will require funding separate from this trial. |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive Without Progression (Progression-free Survival) | IMRT + Cisplatin + Placebo | 34.6 | 95% Confidence Interval 21.2 to 48.0 | percentage of participants | |
| Percentage of Participants Alive Without Progression (Progression-free Survival) | IMRT + Cisplatin + Lapatinib | 43.1 | 95% Confidence Interval 30.1 to 56.1 | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | IMRT + Cisplatin + Placebo | 55.1 | 95% Confidence Interval 40.6 to 69.5 | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | IMRT + Cisplatin + Lapatinib | 49.9 | 95% Confidence Interval 35.5 to 64.3 | percentage of participants | |
| Percentage of Participants With Distant Metastases | IMRT + Cisplatin + Placebo | 19.9 | 95% Confidence Interval 10.1 to 32.2 | percentage of participants | |
| Percentage of Participants With Distant Metastases | IMRT + Cisplatin + Lapatinib | 12.4 | 95% Confidence Interval 5.4 to 22.5 | percentage of participants | |
| Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | IMRT + Cisplatin + Placebo | 84.7 | 95% Confidence Interval 73.0 to 92.8 | percentage of participants | |
| Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | IMRT + Cisplatin + Lapatinib | 86.7 | 95% Confidence Interval 75.4 to 94.1 | percentage of participants | |
| Percentage of Participants Who Complied With Protocol Treatment | IMRT + Cisplatin + Placebo | IMRT | 76.6 | 95% Confidence Interval 66.2 to 86.9 | percentage of participants |
| Percentage of Participants Who Complied With Protocol Treatment | IMRT + Cisplatin + Lapatinib | IMRT | 84.1 | 95% Confidence Interval 75.1 to 93.2 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMRT + Cisplatin + Placebo | 64 | |
| Overall Study | STARTED | IMRT + Cisplatin + Lapatinib | 63 | |
| Overall Study | Participants Who Started Protocol Treatment | IMRT + Cisplatin + Placebo | 59 | |
| Overall Study | Participants Who Started Protocol Treatment | IMRT + Cisplatin + Lapatinib | 60 | |
| Overall Study | COMPLETED | IMRT + Cisplatin + Placebo | 64 | |
| Overall Study | COMPLETED | IMRT + Cisplatin + Lapatinib | 63 | |
| Overall Study | NOT COMPLETED | IMRT + Cisplatin + Placebo | 0 | |
| Overall Study | NOT COMPLETED | IMRT + Cisplatin + Lapatinib | 0 |
Source ClinicalTrials.gov
Adverse events390
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 | Anemia | Blood and lymphatic system disorders | IMRT + Cisplatin + Placebo | 38 | 59 | |
| other | Anemia | Blood and lymphatic system disorders | IMRT + Cisplatin + Lapatinib | 36 | 60 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | IMRT + Cisplatin + Placebo | 7 | 59 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | IMRT + Cisplatin + Lapatinib | 5 | 60 | |
| other | Sinus tachycardia | Cardiac disorders | IMRT + Cisplatin + Placebo | 4 | 59 | |
| other | Sinus tachycardia | Cardiac disorders | IMRT + Cisplatin + Lapatinib | 1 | 60 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT + Cisplatin + Placebo | 14 | 59 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT + Cisplatin + Lapatinib | 12 | 60 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT + Cisplatin + Placebo | 18 | 59 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT + Cisplatin + Lapatinib | 15 | 60 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMRT + Cisplatin + Placebo | 23 | 64 |
| Total, all-cause mortality | IMRT + Cisplatin + Lapatinib | 26 | 63 |
| Total, other adverse events | IMRT + Cisplatin + Placebo | 59 | 59 |
| Total, other adverse events | IMRT + Cisplatin + Lapatinib | 60 | 60 |
| Total, serious adverse events | IMRT + Cisplatin + Placebo | 26 | 59 |
| Total, serious adverse events | IMRT + Cisplatin + Lapatinib | 31 | 60 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMRT + Cisplatin + Placebo vs IMRT + Cisplatin + Lapatinib: deaths from any cause | Trial comparisons |
| IMRT + Cisplatin + Placebo vs IMRT + Cisplatin + Lapatinib: serious adverse events | Trial comparisons |
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/NCT01711658
GET https://conductscience.org/api/trials/v1/NCT01711658/events?page=2