Nasopharyngeal CarcinomaPhase 3NCT00201344
A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
A Phase 3 study testing Cisplatin,5-FU,Leucovorin in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Cisplatin,5-FU,Leucovorin
- How many people
- 320 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 1994to Jan 2000
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
- Original stage must be stage IV disease (M0)
- Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
- Performance status scale ECOG grade 0，1.
- Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl.
- Patients must be younger than 70 year-old.
- Patients must give signed informed consent.
Who cannot join
- Patients had progressive disease after radiotherapy
- Patients had evidence of distant metastasis.
- Patients had completed radiotherapy for more than 7 weeks.
- The presence of life-threatening illness
- History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
- Previous chemotherapy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
Read the detailed description
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.
Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cisplatin,5-FU,Leucovorin
- Keywords
- Radiotherapy, Adjuvant chemotherapy, Chemtherapy, Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin,5-FU,LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival, relapse free survival,distant metastasis and local-regional control rates.
Secondary outcomes (1)
toxicities of the two treatment methods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 1994
- Study completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Kaohsiung Medical University, Kaohsiung Veterans General Hospital., Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital
- Investigators
- Kwan-Hwa Chi, MD,, Principal investigator, Taiwan cooperative oncology group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201344
- Sponsor's protocol ID
- T1394
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 26 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00201344
- Acronym / sponsor ID
- T1394
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Radiotherapy, Adjuvant chemotherapy, Chemtherapy, Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 320 participants
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Kaohsiung Medical University, Kaohsiung Veterans General Hospital., Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital
- Study start
- Nov 1994
- Study completion
- Jan 2000
- First posted
- 20 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.
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
Detailed description
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.
Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
- Original stage must be stage IV disease (M0)
- Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
- Performance status scale ECOG grade 0，1.
- Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl.
Key exclusion criteria (7 listed)
- Patients had progressive disease after radiotherapy
- Patients had evidence of distant metastasis.
- Patients had completed radiotherapy for more than 7 weeks.
- The presence of life-threatening illness
- History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
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 |
|---|---|---|
| Cisplatin,5-FU,Leucovorin | Drug | – |
Primary outcome
overall survival, relapse free survival,distant metastasis and local-regional control rates.
1 secondary outcome
toxicities of the two treatment methods.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
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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.
Kwan-Hwa Chi, MD, principal investigator
Taiwan cooperative oncology group
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 Cisplatin,5-FU,Leucovorin in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Mar 2010. 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 Taiwan. 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. 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 was stopped early. Results are not available in the source record.
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?
overall survival, relapse free survival,distant metastasis and local-regional control rates.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2010.