Nasopharyngeal CarcinomaPhase 2TPF for NPCNCT00817583
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
A Phase 2 study testing docetaxel, cisplatin, fluorouracil and 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- docetaxel, cisplatin, fluorouracil and 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jul 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- Stage Ⅲ, IVa and IVb disease
- KPS >70
- Age between 18-70
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
- the primary tumor or involved lymph node must be more than 2CM in diameter.
- No prior radiation treatment to the head and neck or any prior chemotherapy
- Patients with no prior malignancy (not include basal cell carcinoma of skin)
Who cannot join
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- Prior radiotherapy to the head and neck region for any reason.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaoshen Wang, M.D., 86-21-64175590 ext. 6516, wangxiaoshen@gmail.com
TingTing Xu, M.D., 86-21-64175590 ext. 6511, littlepuppyxtt@gmail.com
About this study
Official title: Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.
The third objective of this study is to evaluate who may benifit from this treatment regimen.
Read the detailed description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- docetaxel, cisplatin, fluorouracil, 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
- Keywords
- Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, cisplatin, fluorouracilDrug
neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
concurrent chemotherapy:cisplatin 40 mg/m2 weekly
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)Radiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2. Receives: Drug: docetaxel, cisplatin, fluorouracil; Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 and 5 years
Secondary outcomes (1)
distant metastases free survival , and disease-free survival
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010 (estimated)
- Study completionJul 2011 (estimated)
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.
- More trials run by Fudan 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoShen WANG, M.D., Principal investigator, Department of Radiation Oncology, Cancer Hospital, Fudan UniversityChaoSu HU, M.D., Study chair, Department of Radiation Oncology, Cancer Hospital, Fudan UniversityChunYing Shen, M.D., Principal investigator, Department of Radiation Oncology, Cancer Hospital, Fudan UniversityHongMei Ying, M.D., Principal investigator, Department of Radiation Oncology, Cancer Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817583
- Sponsor's protocol ID
- NPC20081
- Other IDs
- NPC20081, NPC20081-1
- Acronym
- TPF for NPC
- Status last verified
- Jan 2009
- First submitted
- 5 Jan 2009
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00817583
- Acronym / sponsor ID
- TPF for NPC / NPC20081
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 6 Jan 2009 (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.
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.
The third objective of this study is to evaluate who may benifit from this treatment regimen.
Detailed description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: docetaxel, cisplatin, fluorouracil, Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- Stage Ⅲ, IVa and IVb disease
- KPS >70
- Age between 18-70
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
Key exclusion criteria (5 listed)
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- Prior radiotherapy to the head and neck region for any reason.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
- Pregnant women
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 |
|---|---|---|
| docetaxel, cisplatin, fluorouracilneoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly | Drug | 1 |
| 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) | Radiation | 1 |
Primary outcome
overall survival
Time frame: 3 and 5 years
1 secondary outcome
distant metastases free survival , and disease-free survival
Time frame: 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
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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.
XiaoShen WANG, M.D. principal investigator
Department of Radiation Oncology, Cancer Hospital, Fudan University
ChaoSu HU, M.D. study chair
Department of Radiation Oncology, Cancer Hospital, Fudan University
ChunYing Shen, M.D. principal investigator
Department of Radiation Oncology, Cancer Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, cisplatin, fluorouracil and 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jan 2009. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChaoSu HU, M.D. (86-21-64175590 ext. 6517, hucsu62@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 and 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 27 Jan 2009.