Nasopharyngeal CancerPhase 2NCT03175939
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma
A Phase 2 study testing Radiotherapy, Cisplatin and 5-FU in people with Nasopharyngeal Cancer, run by Sun Yat-sen University.
Trial summary
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Radiotherapy, Cisplatin and 5-FU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 1998to 31 Dec 2014
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) biopsy-proven carcinoma of the nasopharynx,
- (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
- (3) normal renal function (Cr < 1.6 mg/dl),
Who cannot join
- open-neck lymph node biopsy
- previous chemotherapy or radiotherapy to the head and neck region
- distant metastasis or other malignant diseases except skin cancer
About this study
Official title: Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.
Read the detailed description
The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)
- Conditions
- Nasopharyngeal Cancer
- Keywords
- adjuvant chemotherapy, NPC
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
External beam radiotherapy with curative intent, at least 66 Gy
CisplatinDrug
Also called CDDP
cisplatin IV injection over 3 hours
5-FUDrug
Also called 5-fluorouracil
5-FU IV 24 hours continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| CCRT alone | Experimental | External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy Receives: Radiation: Radiotherapy; Drug: Cisplatin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant-metastasis-free survival
percentage of patients who survived and has no distant metastasis
Measured: 5 years
Secondary outcomes (2)
overall survival
percentage of patients who survived
Measured: 5 years
disease-free survival
percentage of patients who survived and had no disease recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Apr 1998
- Primary completion31 Dec 2008
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Shing Wu, Sun Yat-sen University
- Investigators
- Skye Hung-Chun Cheng, M.D., Principal investigator, Koo Foundation Sun Yat-Sen Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175939
- Sponsor's protocol ID
- NPC9801
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
- ClinicalTrials.gov ID
- NCT03175939
- Acronym / sponsor ID
- NPC9801
- Conditions
- Nasopharyngeal Cancer
- Keywords
- adjuvant chemotherapy, NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 1998 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.
Detailed description
The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCRT alone | Experimental | Radiation: Radiotherapy, Drug: Cisplatin, Drug: 5-FUExternal beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) biopsy-proven carcinoma of the nasopharynx,
- (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
- (3) normal renal function (Cr < 1.6 mg/dl),
Key exclusion criteria (3 listed)
- open-neck lymph node biopsy
- previous chemotherapy or radiotherapy to the head and neck region
- distant metastasis or other malignant diseases except skin 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 |
|---|---|---|
| RadiotherapyExternal beam radiotherapy with curative intent, at least 66 Gy | Radiation | CCRT alone |
| CisplatinAlso: CDDPcisplatin IV injection over 3 hours | Drug | CCRT alone |
| 5-FUAlso: 5-fluorouracil5-FU IV 24 hours continuous infusion | Drug | CCRT alone |
Primary outcome
Distant-metastasis-free survival
Time frame: 5 years
percentage of patients who survived and has no distant metastasis
2 secondary outcomes
overall survival
Time frame: 5 years
disease-free survival
Time frame: 5 years
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 5 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Skye Hung-Chun Cheng, M.D. principal investigator
Koo Foundation Sun Yat-Sen Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Cisplatin and 5-FU in people with Nasopharyngeal Cancer, run by Sun Yat-sen University.
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 3 inclusion and 3 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Distant-metastasis-free survival (time frame: 5 years). 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 5 Jun 2017.