Trial · NCT00390806
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
NCT00390806, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer. Trials, record NCT00390806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00390806
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
- NCT number
- NCT00390806
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 472 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Cancer, Non-Small Cell
- Interventions
- HYCAMTIN, oral capsules, Radiation
- First posted
- 2006-10-20
- Last updated
- 2014-01-20
- Results first posted
- 2014-01-20
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From the time of Randomization until the date of death due to any cause (up to 195 weeks) | Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored. |
| Secondary | Six-month Survival | Month 6 | Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored. |
| Secondary | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | From the time of Randomization until the time of CR or PR (up to 75 weeks) | The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses. |
| Secondary | Time to Response (TTR) (CNS-radiologic) | From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks) | TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses. |
| Secondary | Time to Progression (TTP) (CNS-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. |
| Secondary | Time to Progression (TTP) (All Sites of Disease-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. |
| Secondary | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Months 1 and 3 | Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG). |
| Secondary | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma. |
| Secondary | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Secondary | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From the time of Randomization until the date of death due to any cause (up to 195 weeks) | Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received. | months | MEDIAN |
| SECONDARY | Six-month Survival | Month 6 | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | From the time of Randomization until the time of CR or PR (up to 75 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Time to Response (TTR) (CNS-radiologic) | From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks) | ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. | weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) (CNS-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | ITT Population | weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) (All Sites of Disease-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | ITT Population | weeks | MEDIAN |
| SECONDARY | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Months 1 and 3 | ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point. | participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group888
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Chemoradiation: Topotecan Plus WBRT | 4.0 | 95% Confidence Interval 3.4 to 4.8 | months | |
| Overall Survival | Radiation: WBRT Alone | 3.6 | 95% Confidence Interval 3.0 to 4.0 | months | |
| Six-month Survival | Chemoradiation: Topotecan Plus WBRT | 36 | percentage of participants | ||
| Six-month Survival | Radiation: WBRT Alone | 28 | percentage of participants | ||
| Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Chemoradiation: Topotecan Plus WBRT | Complete response | 23 | participants | |
| Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Radiation: WBRT Alone | Complete response | 11 | participants | |
| Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Chemoradiation: Topotecan Plus WBRT | Partial response | 63 | participants | |
| Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Radiation: WBRT Alone | Partial response | 61 | participants | |
| Time to Response (TTR) (CNS-radiologic) | Chemoradiation: Topotecan Plus WBRT | 8.0 | 95% Confidence Interval 7.7 to 8.1 | weeks | |
| Time to Response (TTR) (CNS-radiologic) | Radiation: WBRT Alone | 8.1 | 95% Confidence Interval 6.0 to 8.1 | weeks |
1 to 10 of 888Source ClinicalTrials.gov
See all 888 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiation: Topotecan Plus WBRT | 236 | |
| Overall Study | STARTED | Radiation: WBRT Alone | 236 | |
| Overall Study | Ongoing | Chemoradiation: Topotecan Plus WBRT | 4 | |
| Overall Study | Ongoing | Radiation: WBRT Alone | 2 | |
| Overall Study | COMPLETED | Chemoradiation: Topotecan Plus WBRT | 206 | |
| Overall Study | COMPLETED | Radiation: WBRT Alone | 204 | |
| Overall Study | NOT COMPLETED | Chemoradiation: Topotecan Plus WBRT | 30 | |
| Overall Study | NOT COMPLETED | Radiation: WBRT Alone | 32 |
Source ClinicalTrials.gov
Adverse events816
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 | Nausea | Gastrointestinal disorders | Chemoradiation: Topotecan Plus WBRT | 64 | 235 | |
| other | Nausea | Gastrointestinal disorders | Radiation: WBRT Alone | 30 | 233 | |
| other | Vomiting | Gastrointestinal disorders | Chemoradiation: Topotecan Plus WBRT | 37 | 235 | |
| other | Vomiting | Gastrointestinal disorders | Radiation: WBRT Alone | 24 | 233 | |
| other | Diarrhoea | Gastrointestinal disorders | Chemoradiation: Topotecan Plus WBRT | 19 | 235 | |
| other | Diarrhoea | Gastrointestinal disorders | Radiation: WBRT Alone | 8 | 233 | |
| other | Dyspepsia | Gastrointestinal disorders | Chemoradiation: Topotecan Plus WBRT | 17 | 235 | |
| other | Dyspepsia | Gastrointestinal disorders | Radiation: WBRT Alone | 10 | 233 | |
| other | Constipation | Gastrointestinal disorders | Chemoradiation: Topotecan Plus WBRT | 8 | 235 | |
| other | Constipation | Gastrointestinal disorders | Radiation: WBRT Alone | 10 | 233 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiation: Topotecan Plus WBRT | ||
| Total, all-cause mortality | Radiation: WBRT Alone | ||
| Total, other adverse events | Chemoradiation: Topotecan Plus WBRT | 192 | 235 |
| Total, other adverse events | Radiation: WBRT Alone | 139 | 233 |
| Total, serious adverse events | Chemoradiation: Topotecan Plus WBRT | 96 | 235 |
| Total, serious adverse events | Radiation: WBRT Alone | 43 | 233 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemoradiation: Topotecan Plus WBRT vs Radiation: WBRT Alone: Number of Participants Who Died or Progressed | Trial comparisons |
| Chemoradiation: Topotecan Plus WBRT vs Radiation: WBRT Alone: 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/NCT00390806
GET https://conductscience.org/api/trials/v1/NCT00390806/registered?page=2