Head and Neck Squamous Cell CancerPhase 3NCT02485548
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
A Phase 3 study testing Raltitrexed, 5-fluorouracil and Cisplatin in people with Head and Neck Squamous Cell Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Cancer
- What is being tested?
- Raltitrexed, 5-fluorouracil and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed untreated head and neck squamous cell cancer patients
- 18-70 years
- Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- Renal function: Cr ≤ 1.25×UNL
- Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
Show all 9Show fewer
- ECOG ≤ 1
- Woman and man of childbearing age must adopt contraception
- With written consent
Who cannot join
- Malignant history
- Pregnant or lactating women
- With other severe diseases (blood, liver ,kidney or heart diseases)
- Subjects not suitable for chemo-radiotherapy
- Without written consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Xuesong Jiang, M.D., 13851700790@126.com
Xuesong Jiang, M.D.
About this study
Official title: A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer
This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
Read the detailed description
The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
- Conditions
- Head and Neck Squamous Cell Cancer
- Being tested
- Raltitrexed, 5-fluorouracil, Cisplatin, IMRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
Patients will receive IMRT and concurrent raltitrexed and cisplatin
5-fluorouracilDrug
Patients will receive IMRT and concurrent 5-Fu and cisplatin
CisplatinDrug
All patients will receive concurrent cisplatin.
IMRTRadiation
All patients will receive IMRT
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed plus cisplatin | Experimental | Raltitrexed plus cisplatin and IMRT Receives: Drug: Raltitrexed; Drug: Cisplatin; Radiation: IMRT |
| 5-fluorouracil plus cisplatin | Active comparator | 5-fluorouracil plus cisplatin and IMRT Receives: Drug: 5-fluorouracil; Drug: Cisplatin; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 36 months
Secondary outcomes (3)
Overall Survival (OS)
Measured: 36 months
Locoregional and distant control rate
Measured: 36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CancerStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu People's Hospital, The Second Hospital of Nanjing Medical University, Nanjing BenQ Hospital
- Responsible party
- Principal investigator, Dr. Xia He, Jiangsu Cancer Institute & Hospital
- Investigators
- Xia He, M.D., Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485548
- Sponsor's protocol ID
- 2014NL-035
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT02485548
- Acronym / sponsor ID
- 2014NL-035
- Conditions
- Head and Neck Squamous Cell Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiangnan University, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu People's Hospital, The Second Hospital of Nanjing Medical University, Nanjing BenQ Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Jun 2015 (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.
This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
Detailed description
The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed plus cisplatin | Experimental | Drug: Raltitrexed, Drug: Cisplatin, Radiation: IMRTRaltitrexed plus cisplatin and IMRT |
| 5-fluorouracil plus cisplatin | Active comparator | Drug: 5-fluorouracil, Drug: Cisplatin, Radiation: IMRT5-fluorouracil plus cisplatin and IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically confirmed untreated head and neck squamous cell cancer patients
- 18-70 years
- Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- Renal function: Cr ≤ 1.25×UNL
Key exclusion criteria (5 listed)
- Malignant history
- Pregnant or lactating women
- With other severe diseases (blood, liver ,kidney or heart diseases)
- Subjects not suitable for chemo-radiotherapy
- Without written consent
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 |
|---|---|---|
| RaltitrexedPatients will receive IMRT and concurrent raltitrexed and cisplatin | Drug | Raltitrexed plus cisplatin |
| 5-fluorouracilPatients will receive IMRT and concurrent 5-Fu and cisplatin | Drug | 5-fluorouracil plus cisplatin |
| CisplatinAll patients will receive concurrent cisplatin. | Drug | 5-fluorouracil plus cisplatin, Raltitrexed plus cisplatin |
| IMRTAll patients will receive IMRT | Radiation | 5-fluorouracil plus cisplatin, Raltitrexed plus cisplatin |
Primary outcome
Progression-free survival (PFS)
Time frame: 36 months
3 secondary outcomes
Overall Survival (OS)
Time frame: 36 months
Locoregional and distant control rate
Time frame: 36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
Related trials for Head and Neck Squamous Cell Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
Xia He, M.D. principal investigator
Jiangsu Cancer Institute & Hospital
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 Raltitrexed, 5-fluorouracil and Cisplatin in people with Head and Neck Squamous Cell Cancer, run by Jiangsu Cancer Institute & Hospital 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 9 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 30 Jun 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuesong Jiang, M.D. (86138517007, 13851700790@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 36 months). 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 30 Jun 2015.