Nasopharyngeal CarcinomaPhase 3NCT00201396
A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
A Phase 3 study testing CCRT and Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial summary
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC. 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?
- CCRT and Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 4 sitesTaiwan
- Study dates
- Aug 2003to Dec 2011
- 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
- Histologically proved nasopharyngeal carcinoma.
- T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
- Eastern Cooperative Oncology Group performance status < 2.
- A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
- A serum bilirubin level < 1.5 mg/dL, serum creatinine level < 1.6 mg/dL or creatinine clearance > 60 mL/min.
- Age less than 70 years old
- An informed consent signed.
Who cannot join
- Evidence of metastatic disease.
- Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- Presence of uncontrolled hypertension, poorly controlled heart failure.
- Presence of active infection.
- Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
- Women who test positive for pregnancy.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 80708
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 115
Chang-Gung Memorial Hospital(Lin-Kou),
Taoyuan, 333
About this study
Official title: A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Read the detailed description
Rationale of induction chemotherapy:
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC.
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.
Objectives:
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Study design:
This is a randomized, multi-center Phase III study. Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy.
Type and number of patients:
Patients with stage IVA (T4) and/or IVB (N3) but without distant metastasis will be enrolled. A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a two-sided logrank test with one interim analysis.
Treatment schedule:
Induction chemotherapy and CCRT:
Arm A: Weekly cisplatin concurrently with radiotherapy Arm B: Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy.
Study endpoints:
The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after +induction chemotherapy/CCRT, or death from any cause (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).( revised 8/27/2004)
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- CCRT, Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
- Keywords
- A Multicenter Phase III Trial, Induction Chemotherapy, Concurrent Chemoradiotherapy, Stage IV Nasopharyngeal Carcinoma (NPC), randomization, disease-free survival
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRTRadiation
Radiation with weekly Cisplatin
Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,LeucovorinDrug
Induction C/T + CCRT
| Study group | Role | What they receive |
|---|---|---|
| A arm | Active comparator | CCRT Receives: Radiation: CCRT |
| B arm | Experimental | Induction/CCRT Receives: Radiation: CCRT; Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the disease-free survival.
follow up for 2 years after off study treatment
Measured: 10 years
Secondary outcomes (1)
Secondary endpoints include overall survival and tumor response rate.
follow up for 2 years after off study treatment
Measured: 10 years
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 startAug 2003
- Primary completionAug 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 480 participants (actual)
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), Chang Gung Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Changhua Christian Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ruey-Long Hong, MD, PhD, Principal investigator, Taiwan cooperative oncology group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201396
- Sponsor's protocol ID
- T1303
- Status last verified
- May 2006
- First submitted
- 13 Sep 2005
- Last updated
- 25 Feb 2015
- Results posted
- No
Publications
Hong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC, Lou PJ, Wang HM, Tsai MH, Lai SC, Liu TW. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Ann Oncol. 2018 Sep 1;29(9):1972-1979. doi: 10.1093/annonc/mdy249.
PubMed 30016391
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT00201396
- Acronym / sponsor ID
- T1303
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- A Multicenter Phase III Trial, Induction Chemotherapy, Concurrent Chemoradiotherapy, Stage IV Nasopharyngeal Carcinoma (NPC), randomization, disease-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Chang Gung Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Changhua Christian Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Taipei Veterans General Hospital, Taiwan
- Study start
- Aug 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2011 (actual)
- 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.
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Detailed description
Rationale of induction chemotherapy:
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC.
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.
Objectives:
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Study design:
This is a randomized, multi-center Phase III study. Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy.
Type and number of patients:
Patients with stage IVA (T4) and/or IVB (N3) but without distant metastasis will be enrolled. A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a two-sided logrank test with one interim analysis.
Treatment schedule:
Induction chemotherapy and CCRT:
Arm A: Weekly cisplatin concurrently with radiotherapy Arm B: Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy.
Study endpoints:
The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after +induction chemotherapy/CCRT, or death from any cause (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).( revised 8/27/2004)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A arm | Active comparator | Radiation: CCRTCCRT |
| B arm | Experimental | Radiation: CCRT, Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,LeucovorinInduction/CCRT |
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)
- Histologically proved nasopharyngeal carcinoma.
- T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
- Eastern Cooperative Oncology Group performance status < 2.
- A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
- A serum bilirubin level < 1.5 mg/dL, serum creatinine level < 1.6 mg/dL or creatinine clearance > 60 mL/min.
Key exclusion criteria (6 listed)
- Evidence of metastatic disease.
- Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- Presence of uncontrolled hypertension, poorly controlled heart failure.
- Presence of active infection.
- Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
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 |
|---|---|---|
| CCRTRadiation with weekly Cisplatin | Radiation | A arm, B arm |
| Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,LeucovorinInduction C/T + CCRT | Drug | B arm |
Primary outcome
The primary endpoint is the disease-free survival.
Time frame: 10 years
follow up for 2 years after off study treatment
1 secondary outcome
Secondary endpoints include overall survival and tumor response rate.
Time frame: 10 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 25 Feb 2015.
- Derived from this study: PubMed 30016391Hong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC, Lou PJ, Wang HM, Tsai MH, Lai SC, Liu TW. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Ann Oncol. 2018 Sep 1;29(9):1972-1979. doi: 10.1093/annonc/mdy249.
- Related InfoLink provided by the sponsor.
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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.
Ruey-Long Hong, MD, PhD principal investigator
Taiwan cooperative oncology group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CCRT and Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 4 sites 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 6 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 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
The primary endpoint is the disease-free survival. (time frame: 10 years). 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 NCT00201396, which also lists 1 linked publication.
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 25 Feb 2015.