Hypopharyngeal CancerPhase 3NCT04502641
Induction Chemotherapy in Locally Advanced Hypopharyngeal Carcinoma: a Randomised Phase 3 Trial
A Phase 3 study testing Docetaxel, 5-fluorouracil and Cisplatin in people with Hypopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hypopharyngeal cancer is an important part of head and neck cancer, with more than 80,000 new cases in 2018. And it is a highly aggressive cancer often diagnosed at an advanced stage. which expresses poor survival, the 5-year overall survival (OS) is about only 30%-35%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypopharyngeal Cancer
- What is being tested?
- Docetaxel, 5-fluorouracil and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female, aged 18 to 75 years; 2. Performance status (PS) score ≤ 2 points; 3. The expected survival period is more than 3 months; 4. Patients have histopathologically confirmed hypopharyngeal squamous cell carcinoma, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with stage III and IVA-B (TNM stageT1-2N1-3M0/T3-4aN0-3M0) according to the AJCC 8th edition; 5. With measurable lesions: According to the evaluation criteria for the efficacy of solid tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at least one measurable lesion. The measurable lesion should not have received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area, if it is confirmed that significant progress has occurred , And comply with evaluation standard, can also be used as target lesions); 6. No previous anti-tumor therapy, including anti-angiogenesis therapy, such as pazopanib, sunitinib, sorafenib, regorafenib, etc.; 7. Sufficient liver function: total bilirubin ≤ upper limit of normal value (ULN); glutamic oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) ≤ 2 times upper limit of normal value (ULN); alkaline phosphatase ≤ 5 times upper limit of normal value (ULN); 8. Adequate renal function: creatinine clearance rate ≥80 mL/min; 9. Adequate blood function: absolute neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9g/dL; 10. No serious heart, lung and other important organ dysfunction; 11. Women of childbearing age must have taken reliable contraceptive measures; pregnancy tests (serum or urine) are negative within 7 days before enrollment, and must be non-lactating patients; and are willing to adopt appropriate during the test and within 6 months after the last treatment Methods of contraception. For men, it is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last dose; 12. The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with the follow-up.
Who cannot join
- 1. Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer; 2. Patients with target lesions who have received radiation therapy or surgery (except biopsy); 3. Treatment with palliative intent; 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes; 5. Any severe coexisting disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yong Chen, 8602087338692, chenyong@mail.sysu.edu.cn
About this study
Official title: A Randomized Phase III Comparing Sequential Therapy With Induction Chemotherapy/Chemoradiation To Cisplatinum-Based Chemoradiotherapy in Locally Advanced Hypopharyngeal Carcinoma
Hypopharyngeal cancer is an important part of head and neck cancer, with more than 80,000 new cases in 2018. And it is a highly aggressive cancer often diagnosed at an advanced stage. which expresses poor survival, the 5-year overall survival (OS) is about only 30%-35%. Given the complexity of these tumors, their surrounding structures, the frequent comorbidities, and the improvement of patients' requirements for quality of life, a multidisciplinary treatment approach should be applied to achieve the best oncological outcomes and to improve functional results. This benefi t of induction chemotherapy has been recorded in patients with both resectable and unresectable disease. It has also been observed in patients with laryngeal cancer treated for organ preservation. However, whether the addition of induction chemotherapy to chemoradiotherapy improves efficacy compared with chemoradiotherapy alone is unclear in hypopharyngeal cancer.We tried to observe the clinical treatment efficiency, toxic and side effects, progression-free survival time, overall survival time and quality of life of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide patients with a more optimal treatment plan and improve survival.
Read the detailed description
We will prospectively collect 160 patients who were randomly assigned (in a 1:1 ratio) to receive either induction chemotherapy followed by concurrent chemoradiotherapy (group A) or definitive concurrent chemoradiotherapy (group B). Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.
- Conditions
- Hypopharyngeal Cancer
- Being tested
- Docetaxel, 5-fluorouracil, Cisplatin, Intensity Modulated Radiation Therapy, Platinum
- Keywords
- hypopharyngeal carcinoma, chemotherapy, radiotherapy, prognosis
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxol
60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
5-fluorouracilDrug
600 mg/m² per day as a continuous 120 h infusion on days 1-5, 3 weeks as one cycle, for 3 cycles.
CisplatinDrug
60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
Intensity Modulated Radiation TherapyRadiation
The treatment consisted of definitive radiotherapy with conventional fractionation, a total dose of 68-70 Gy to PTVp, 62-68 Gy to PTVn, 60-62 Gy to PTV-HR, and 50-54 Gy to PTV-LR.
PlatinumDrug
100mg/m2 on day 1, 3 weeks as one cycle, during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive induction chemotherapy with docetaxel-based, with or without cisplatin or fluorouracil. Treatment repeats every 21 days for 3 courses. Then, patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks. Receives: Drug: Docetaxel; Drug: 5-fluorouracil; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy; Drug: Platinum |
| Arm II | Active comparator | Patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks. Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (RFS)
Measured from the date of treatment end to recurrent/residual tumor was diagnose or to the time of the last follow-up, whichever occurred first，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.
Measured: 3 month
Secondary outcomes (2)
Overall-survival (OS)
Defined as the interval between the time of treatment end to death or to the last date of follow-up，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.
Measured: 3 month
Adverse events rate
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Wei Peng, Sun Yat-sen University
- Investigators
- Yong Chen, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502641
- Sponsor's protocol ID
- hypopharyngeal SCC 001
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Comparing Sequential Therapy With Induction Chemotherapy/Chemoradiation To Cisplatinum-Based Chemoradiotherapy in Locally Advanced Hypopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04502641
- Acronym / sponsor ID
- hypopharyngeal SCC 001
- Conditions
- Hypopharyngeal Cancer
- Keywords
- hypopharyngeal carcinoma, chemotherapy, radiotherapy, prognosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Aug 2020 (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.
Hypopharyngeal cancer is an important part of head and neck cancer, with more than 80,000 new cases in 2018. And it is a highly aggressive cancer often diagnosed at an advanced stage. which expresses poor survival, the 5-year overall survival (OS) is about only 30%-35%. Given the complexity of these tumors, their surrounding structures, the frequent comorbidities, and the improvement of patients' requirements for quality of life, a multidisciplinary treatment approach should be applied to achieve the best oncological outcomes and to improve functional results. This benefi t of induction chemotherapy has been recorded in patients with both resectable and unresectable disease. It has also been observed in patients with laryngeal cancer treated for organ preservation. However, whether the addition of induction chemotherapy to chemoradiotherapy improves efficacy compared with chemoradiotherapy alone is unclear in hypopharyngeal cancer.We tried to observe the clinical treatment efficiency, toxic and side effects, progression-free survival time, overall survival time and quality of life of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide patients with a more optimal treatment plan and improve survival.
Detailed description
We will prospectively collect 160 patients who were randomly assigned (in a 1:1 ratio) to receive either induction chemotherapy followed by concurrent chemoradiotherapy (group A) or definitive concurrent chemoradiotherapy (group B). Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Docetaxel, Drug: 5-fluorouracil, Drug: Cisplatin, Radiation: Intensity Modulated Radiation Therapy, Drug: PlatinumPatients receive induction chemotherapy with docetaxel-based, with or without cisplatin or fluorouracil. Treatment repeats every 21 days for 3 courses. Then, patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks. |
| Arm II | Active comparator | Radiation: Intensity Modulated Radiation Therapy, Drug: PlatinumPatients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Male or female, aged 18 to 75 years; 2. Performance status (PS) score ≤ 2 points; 3. The expected survival period is more than 3 months; 4. Patients have histopathologically confirmed hypopharyngeal squamous cell carcinoma, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with stage III and IVA-B (TNM stageT1-2N1-3M0/T3-4aN0-3M0) according to the AJCC 8th edition; 5. With measurable lesions: According to the evaluation criteria for the efficacy of solid tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at least one measurable lesion. The measurable lesion should not have received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area, if it is confirmed that significant progress has occurred , And comply with evaluation standard, can also be used as target lesions); 6. No previous anti-tumor therapy, including anti-angiogenesis therapy, such as pazopanib, sunitinib, sorafenib, regorafenib, etc.; 7. Sufficient liver function: total bilirubin ≤ upper limit of normal value (ULN); glutamic oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) ≤ 2 times upper limit of normal value (ULN); alkaline phosphatase ≤ 5 times upper limit of normal value (ULN); 8. Adequate renal function: creatinine clearance rate ≥80 mL/min; 9. Adequate blood function: absolute neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9g/dL; 10. No serious heart, lung and other important organ dysfunction; 11. Women of childbearing age must have taken reliable contraceptive measures; pregnancy tests (serum or urine) are negative within 7 days before enrollment, and must be non-lactating patients; and are willing to adopt appropriate during the test and within 6 months after the last treatment Methods of contraception. For men, it is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last dose; 12. The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with the follow-up.
Key exclusion criteria (1 listed)
- 1. Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer; 2. Patients with target lesions who have received radiation therapy or surgery (except biopsy); 3. Treatment with palliative intent; 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes; 5. Any severe coexisting disease.
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 |
|---|---|---|
| DocetaxelAlso: Taxol60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles. | Drug | Arm I |
| 5-fluorouracil600 mg/m² per day as a continuous 120 h infusion on days 1-5, 3 weeks as one cycle, for 3 cycles. | Drug | Arm I |
| Cisplatin60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles. | Drug | Arm I |
| Intensity Modulated Radiation TherapyThe treatment consisted of definitive radiotherapy with conventional fractionation, a total dose of 68-70 Gy to PTVp, 62-68 Gy to PTVn, 60-62 Gy to PTV-HR, and 50-54 Gy to PTV-LR. | Radiation | Arm I, Arm II |
| Platinum100mg/m2 on day 1, 3 weeks as one cycle, during radiotherapy. | Drug | Arm I, Arm II |
Primary outcome
Progression-free survival (RFS)
Time frame: 3 month
Measured from the date of treatment end to recurrent/residual tumor was diagnose or to the time of the last follow-up, whichever occurred first，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.
2 secondary outcomes
Overall-survival (OS)
Time frame: 3 month
Adverse events rate
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
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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.
Yong Chen principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 Docetaxel, 5-fluorouracil and Cisplatin in people with Hypopharyngeal Cancer, run by Sun Yat-sen 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 1 inclusion and 1 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 6 Aug 2020. 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 Yong Chen (+862087755766, chenyong@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (RFS) (time frame: 3 month). 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 6 Aug 2020.