NeoplasmsPhase 3NCT00169845
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
A Phase 3 study testing Alpha-Tocopherol and Beta-Carotene in people with Neoplasms, run by Laval University at 1 site in Canada.
Trial summary
Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Alpha-Tocopherol and Beta-Carotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteCanada
- Study dates
- Oct 1994to Mar 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented stage I or II head and neck cancer
Who cannot join
- Karnofsky performance score of less than 60
- Multiple primary head and neck cancer
- History of cancer
- Severe cardiovascular disease
- Inadequate renal, hepatic or hematologic function
- Anticoagulant therapy
- Pregnancy
- Average daily supplement intake of beta-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively.
Trial locations and contacts
1 site in 1 country.
About this study
Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.
In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.
Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).
- Conditions
- Neoplasms
- Being tested
- Alpha-Tocopherol and Beta-Carotene, Placebo
- Keywords
- chemoprevention trial, antioxidant, alpha-tocopherol, beta-carotene, second primary cancer, head and neck cancer, adverse effect of radiation therapy, quality of life, mortality, cancer free survival, cancer recurrence
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary, Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Tocopherol and Beta-CaroteneDietary supplement
Provided by Roche Vitamins Inc.
PlaceboDietary supplement
Provided by Roche Vitamins Inc
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Tocopherol and Beta-Carotene | Experimental | Patients received a daily supplementation of alpha-tocopherol (one capsule of 400 IU dl-alpha-tocopherol) and beta-carotene (one capsule of 30 mg) for 3 years after the end of radiation therapy. Due to ethical concerns, the beta-carotene supplementation was stopped during the trial (after the randomization of 156 patients). See details in JNCI, 2005: 97 (7), 481-8. Receives: Dietary Supplement: Alpha-Tocopherol and Beta-Carotene |
| Placebo | Placebo comparator | Patients received two capsules of placebos per day during 3 years. When the beta-carotene was stopped, they received only one capsule. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second primary cancers
Measured: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Secondary outcomes (9)
Acute and late side-effects of radiation therapy
Measured: During radiation therapy (RT), at the end of RT, one month after RT, six months after RT and 1 year after RT
Quality of life
Measured: Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT
Recurrence
Measured: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Cancer free survival
Without recurrence and without second primary cancer
Measured: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Overall survival
Measured: Every year
Disease free survival
Alive and without recurrence
Measured: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Survival until death from first cancer
Measured: every year
Survival until death from second primary cancer
Measured: Every year
Survival until death from non-cancer causes
Measured: Every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 1994
- Primary completionJun 2003
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Trials Group, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Isabelle Bairati, Laval University
- Investigators
- Isabelle Bairati, MD, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169845
- Sponsor's protocol ID
- 27370
- Other IDs
- NCIC-4738, NCIC-8176, NCIC-13211, NCIC-019502, 1R03CA141615-01, 018100
- Status last verified
- Mar 2018
- First submitted
- 9 Sep 2005
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A letter was sent to each participant.
Publications
Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Abdous B, Vigneault E, Vass S, Del Vecchio P, Roy J. Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients. J Clin Oncol. 2005 Aug 20;23(24):5805-13. doi: 10.1200/JCO.2005.05.514. Epub 2005 Jul 18.
PubMed 16027437Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Masse B, Vigneault E, Vass S, del Vecchio P, Roy J. A randomized trial of antioxidant vitamins to prevent second primary cancers in head and neck cancer patients. J Natl Cancer Inst. 2005 Apr 6;97(7):481-8. doi: 10.1093/jnci/dji095.
PubMed 15812073Bairati I, Meyer F, Jobin E, Gelinas M, Fortin A, Nabid A, Brochet F, Tetu B. Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients. Int J Cancer. 2006 Nov 1;119(9):2221-4. doi: 10.1002/ijc.22042.
PubMed 16841333Meyer F, Bairati I, Jobin E, Gelinas M, Fortin A, Nabid A, Tetu B. Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Nutr Cancer. 2007;59(1):29-35. doi: 10.1080/01635580701397590.
PubMed 17927499Sackett MK, Bairati I, Meyer F, Jobin E, Lussier S, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Prognostic significance of cyclooxygenase-2 overexpression in glottic cancer. Clin Cancer Res. 2008 Jan 1;14(1):67-73. doi: 10.1158/1078-0432.CCR-07-2028.
PubMed 18172254Meyer F, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Bairati I. Health-related quality of life as a survival predictor for patients with localized head and neck cancer treated with radiation therapy. J Clin Oncol. 2009 Jun 20;27(18):2970-6. doi: 10.1200/JCO.2008.20.0295. Epub 2009 May 18.
PubMed 19451440Meyer F, Samson E, Douville P, Duchesne T, Liu G, Bairati I. Serum prognostic markers in head and neck cancer. Clin Cancer Res. 2010 Feb 1;16(3):1008-15. doi: 10.1158/1078-0432.CCR-09-2014. Epub 2010 Jan 26.
PubMed 20103685Nourissat A, Bairati I, Samson E, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Predictors of weight loss during radiotherapy in patients with stage I or II head and neck cancer. Cancer. 2010 May 1;116(9):2275-83. doi: 10.1002/cncr.25041.
PubMed 20187097Meyer F, Liu G, Douville P, Samson E, Xu W, Adjei A, Bairati I. Dietary vitamin D intake and serum 25-hydroxyvitamin D level in relation to disease outcomes in head and neck cancer patients. Int J Cancer. 2011 Apr 1;128(7):1741-6. doi: 10.1002/ijc.25496. Epub 2010 Jun 7.
PubMed 20533282Meyer F, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Interaction between antioxidant vitamin supplementation and cigarette smoking during radiation therapy in relation to long-term effects on recurrence and mortality: a randomized trial among head and neck cancer patients. Int J Cancer. 2008 Apr 1;122(7):1679-83. doi: 10.1002/ijc.23200.
PubMed 18059031Nourissat A, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Factors associated with weight loss during radiotherapy in patients with stage I or II head and neck cancer. Support Care Cancer. 2012 Mar;20(3):591-9. doi: 10.1007/s00520-011-1132-x. Epub 2011 Mar 20.
PubMed 21424341Meyer F, Fortin A, Wang CS, Liu G, Bairati I. Predictors of severe acute and late toxicities in patients with localized head-and-neck cancer treated with radiation therapy. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1454-62. doi: 10.1016/j.ijrobp.2011.04.022. Epub 2011 Jun 2.
PubMed 21640495Azad AK, Bairati I, Samson E, Cheng D, Cheng L, Mirshams M, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Genetic sequence variants and the development of secondary primary cancers in patients with head and neck cancers. Cancer. 2012 Mar 15;118(6):1554-65. doi: 10.1002/cncr.26446. Epub 2011 Aug 25.
PubMed 22009713Azad AK, Bairati I, Samson E, Cheng D, Mirshams M, Qiu X, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Validation of genetic sequence variants as prognostic factors in early-stage head and neck squamous cell cancer survival. Clin Cancer Res. 2012 Jan 1;18(1):196-206. doi: 10.1158/1078-0432.CCR-11-1759. Epub 2011 Nov 10.
PubMed 22076708Azad AK, Bairati I, Qiu X, Huang H, Cheng D, Liu G, Meyer F, Adjei A, Xu W. Genetic sequence variants in vitamin D metabolism pathway genes, serum vitamin D level and outcome in head and neck cancer patients. Int J Cancer. 2013 Jun 1;132(11):2520-7. doi: 10.1002/ijc.27946. Epub 2012 Dec 14.
PubMed 23169318
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00169845
- Acronym / sponsor ID
- 27370
- Conditions
- Neoplasms
- Keywords
- chemoprevention trial, antioxidant, alpha-tocopherol, beta-carotene, second primary cancer, head and neck cancer, adverse effect of radiation therapy, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Cancer Trials Group, National Cancer Institute (NCI)
- Study start
- Oct 1994
- Primary completion
- Jun 2003 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.
In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.
Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-Tocopherol and Beta-Carotene | Experimental | Dietary Supplement: Alpha-Tocopherol and Beta-CarotenePatients received a daily supplementation of alpha-tocopherol (one capsule of 400 IU dl-alpha-tocopherol) and beta-carotene (one capsule of 30 mg) for 3 years after the end of radiation therapy. Due to ethical concerns, the beta-carotene supplementation was stopped during the trial (after the randomization of 156 patients). See details in JNCI, 2005: 97 (7), 481-8. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients received two capsules of placebos per day during 3 years. When the beta-carotene was stopped, they received only one capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically documented stage I or II head and neck cancer
Key exclusion criteria (8 listed)
- Karnofsky performance score of less than 60
- Multiple primary head and neck cancer
- History of cancer
- Severe cardiovascular disease
- Inadequate renal, hepatic or hematologic function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Tocopherol and Beta-CaroteneProvided by Roche Vitamins Inc. | Dietary supplement | Alpha-Tocopherol and Beta-Carotene |
| PlaceboProvided by Roche Vitamins Inc | Dietary supplement | Placebo |
Primary outcome
Second primary cancers
Time frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
9 secondary outcomes
Acute and late side-effects of radiation therapy
Time frame: During radiation therapy (RT), at the end of RT, one month after RT, six months after RT and 1 year after RT
Quality of life
Time frame: Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT
Recurrence
Time frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Cancer free survival
Time frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Overall survival
Time frame: Every year
Disease free survival
Time frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Survival until death from first cancer
Time frame: every year
Survival until death from second primary cancer
Time frame: Every year
Survival until death from non-cancer causes
Time frame: Every year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Results publication: PubMed 16027437Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Abdous B, Vigneault E, Vass S, Del Vecchio P, Roy J. Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients. J Clin Oncol. 2005 Aug 20;23(24):5805-13. doi: 10.1200/JCO.2005.05.514. Epub 2005 Jul 18.
- Results publication: PubMed 15812073Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Masse B, Vigneault E, Vass S, del Vecchio P, Roy J. A randomized trial of antioxidant vitamins to prevent second primary cancers in head and neck cancer patients. J Natl Cancer Inst. 2005 Apr 6;97(7):481-8. doi: 10.1093/jnci/dji095.
- Results publication: PubMed 16841333Bairati I, Meyer F, Jobin E, Gelinas M, Fortin A, Nabid A, Brochet F, Tetu B. Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients. Int J Cancer. 2006 Nov 1;119(9):2221-4. doi: 10.1002/ijc.22042.
- Results publication: PubMed 17927499Meyer F, Bairati I, Jobin E, Gelinas M, Fortin A, Nabid A, Tetu B. Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Nutr Cancer. 2007;59(1):29-35. doi: 10.1080/01635580701397590.
- Results publication: PubMed 18172254Sackett MK, Bairati I, Meyer F, Jobin E, Lussier S, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Prognostic significance of cyclooxygenase-2 overexpression in glottic cancer. Clin Cancer Res. 2008 Jan 1;14(1):67-73. doi: 10.1158/1078-0432.CCR-07-2028.
- Results publication: PubMed 19451440Meyer F, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Bairati I. Health-related quality of life as a survival predictor for patients with localized head and neck cancer treated with radiation therapy. J Clin Oncol. 2009 Jun 20;27(18):2970-6. doi: 10.1200/JCO.2008.20.0295. Epub 2009 May 18.
- Results publication: PubMed 20103685Meyer F, Samson E, Douville P, Duchesne T, Liu G, Bairati I. Serum prognostic markers in head and neck cancer. Clin Cancer Res. 2010 Feb 1;16(3):1008-15. doi: 10.1158/1078-0432.CCR-09-2014. Epub 2010 Jan 26.
- Results publication: PubMed 20187097Nourissat A, Bairati I, Samson E, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Predictors of weight loss during radiotherapy in patients with stage I or II head and neck cancer. Cancer. 2010 May 1;116(9):2275-83. doi: 10.1002/cncr.25041.
- Results publication: PubMed 20533282Meyer F, Liu G, Douville P, Samson E, Xu W, Adjei A, Bairati I. Dietary vitamin D intake and serum 25-hydroxyvitamin D level in relation to disease outcomes in head and neck cancer patients. Int J Cancer. 2011 Apr 1;128(7):1741-6. doi: 10.1002/ijc.25496. Epub 2010 Jun 7.
- Results publication: PubMed 18059031Meyer F, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Interaction between antioxidant vitamin supplementation and cigarette smoking during radiation therapy in relation to long-term effects on recurrence and mortality: a randomized trial among head and neck cancer patients. Int J Cancer. 2008 Apr 1;122(7):1679-83. doi: 10.1002/ijc.23200.
- Results publication: PubMed 21424341Nourissat A, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Factors associated with weight loss during radiotherapy in patients with stage I or II head and neck cancer. Support Care Cancer. 2012 Mar;20(3):591-9. doi: 10.1007/s00520-011-1132-x. Epub 2011 Mar 20.
- Results publication: PubMed 21640495Meyer F, Fortin A, Wang CS, Liu G, Bairati I. Predictors of severe acute and late toxicities in patients with localized head-and-neck cancer treated with radiation therapy. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1454-62. doi: 10.1016/j.ijrobp.2011.04.022. Epub 2011 Jun 2.
- Individual participant dataSharing planned: Yes. A letter was sent to each participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Bairati, MD, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha-Tocopherol and Beta-Carotene in people with Neoplasms, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Second primary cancers (time frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169845, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.