Nasopharyngeal CancerPhase 2NCT03890185
Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC
A Phase 2 study testing Chemo + Low dose RT and Chemo alone in people with Nasopharyngeal Cancer, run by King Faisal Specialist Hospital & Research Center.
Trial summary
The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Chemo + Low dose RT and Chemo alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 31 Dec 2020
- 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
- WHO II-III carcinoma of the nasopharynx, histologically proven.
- Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases.
- Age between 18 and 70 years.
- ECOG performance status 0-2.
- Hematological function parameters performed within 10 days before inclusion:
- Neutrophils ≥ 1000 * 109/l.
Show all 14Show fewer
- Platelets: ≥ 100 * 109/l.
- Hemoglobin: ≥ 9 g/dl
- Adequate hepatic function, defined as follows within 2 weeks prior to registration:
- Total bilirubin is normal
- AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.
- Alkaline phosphatase <= 2.5 * ULN.
- Renal function parameters performed within 10 days before inclusion: normal serum creatinine and creatinine clearance must be ≥ 55 ml/min.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Who cannot join
- Patients who present stage I, IIa, IIb and IVc.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies.
- Patients receiving other experimental therapeutic cancer treatment;
Show all 14Show fewer
- Blood pressure at baseline > 150/100 mmHg;
- Peripheral neuropathy CTCAE, v. 4.0 h grade 2
- Severe, active co-morbidity, defined as follows:
- Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy.
- Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug.
- Acquired Immune Deficiency.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Prior allergic reaction to the study drug(s) involved in this.
About this study
Official title: Randomized Phase II Trial of Docetaxal and Cisplatin Versus Low-Dose Fractionated Radiation Plus Docetaxal and Cisplatin as Induction Therapy in Locally Advanced Nasopharyngeal Cancer
The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.
Read the detailed description
Nasopharyngeal cancer is the commonest cancer of the head and neck in Saudi Arabia and constitutes nearly a half (44%) of all head and neck cancers diagnosed annually according to the National Cancer Registry Data. Majority of our patients present with locally advance disease which adversely affect their treatment outcome. The treatment of this disease has evolved over the last several years and several Phase III trials have now shown that combined chemotherapy and radiation are significantly superior to treatment with radiation therapy alone. However, results for treatment of the Stage III and IV disease remains less than satisfactory with a 5-year survival of 60-70 %. Recent data in other head and neck cancer sites including nasopharyngeal cancer indicates that the use of chemotherapy in combination with radiation may improve the outcome of therapy primarily by a reduction in the rate of distant metastasis. Induction chemotherapy alone has, however, failed to show an improvement in survival compared to radiation therapy alone. The administration of induction chemotherapy followed by concurrent chemo-radiation appears the most promising approach. Our experience at KFSH\&RC with induction chemotherapy followed by chemo-radiation in Stage IV cancers, still reveals that approximately 25- 30% of patients will develop local relapse in the nasopharyngeal site; and 35- 40 % of patients are likely to develop distant metastasis. The most promising recent schedule of induction chemotherapy has been the use of Docetaxel and Cisplatin followed by concurrent Cisplatin and radiation. A recent Phase II study demonstrated that the three-year progression-free survival and overall survivals was improved with the use of this induction regimen. A variety of treatment strategies are currently being investigated in hope of achieving improved local control and enhanced survival of patients. These include addition of new chemotherapy drugs, other targeted agents such as Bevacizumab, Cetuximab, etc and radiation fractionation. The rationale for using neoadjuvant chemotherapy is that a reduction in the overall tumor burden will permit more effective local therapy and reduce the rates of distant metastases. Neoadjuvant cisplatin / docetaxel are active agents for locally advanced nasopharyngeal cancer. The addition of docetaxel to platinum containing neoadjuvant chemotherapy in other locally advanced head and neck squamous-cell carcinoma have also been shown to improve survival.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Chemo + Low dose RT, Chemo alone
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo + Low dose RTCombination product
Also called Chemotherapy, Low Dose Radiation Therapy
Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days.
Chemo aloneDrug
Also called Chemotherapy
Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| A: Chemo+RT low dose | Experimental | Chemo + Low dose RT: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin (CDDP) 75mg/m2 IV D1 and radiation therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for a total of 2 cycles every 21 days. Receives: Combination Product: Chemo + Low dose RT; Drug: Chemo alone |
| B: Chemo alone | Active comparator | Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days. Receives: Combination Product: Chemo + Low dose RT; Drug: Chemo alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of chemo and radiation toxicities
Chemotherapy and acute radiation toxicities as evaluated using the revised NCI (CTCAE) Version 4.03
Measured: Three years
Secondary outcomes (1)
Distant and loco regional failure
Distant and loco regional failure as evaluated using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Oct 2012
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasser Alrajhi, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890185
- Sponsor's protocol ID
- 2121 063
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Docetaxal and Cisplatin Versus Low-Dose Fractionated Radiation Plus Docetaxal and Cisplatin as Induction Therapy in Locally Advanced Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT03890185
- Acronym / sponsor ID
- 2121 063
- Conditions
- Nasopharyngeal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Mar 2019 (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.
The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.
Detailed description
Nasopharyngeal cancer is the commonest cancer of the head and neck in Saudi Arabia and constitutes nearly a half (44%) of all head and neck cancers diagnosed annually according to the National Cancer Registry Data. Majority of our patients present with locally advance disease which adversely affect their treatment outcome. The treatment of this disease has evolved over the last several years and several Phase III trials have now shown that combined chemotherapy and radiation are significantly superior to treatment with radiation therapy alone. However, results for treatment of the Stage III and IV disease remains less than satisfactory with a 5-year survival of 60-70 %. Recent data in other head and neck cancer sites including nasopharyngeal cancer indicates that the use of chemotherapy in combination with radiation may improve the outcome of therapy primarily by a reduction in the rate of distant metastasis. Induction chemotherapy alone has, however, failed to show an improvement in survival compared to radiation therapy alone. The administration of induction chemotherapy followed by concurrent chemo-radiation appears the most promising approach. Our experience at KFSH\&RC with induction chemotherapy followed by chemo-radiation in Stage IV cancers, still reveals that approximately 25- 30% of patients will develop local relapse in the nasopharyngeal site; and 35- 40 % of patients are likely to develop distant metastasis. The most promising recent schedule of induction chemotherapy has been the use of Docetaxel and Cisplatin followed by concurrent Cisplatin and radiation. A recent Phase II study demonstrated that the three-year progression-free survival and overall survivals was improved with the use of this induction regimen. A variety of treatment strategies are currently being investigated in hope of achieving improved local control and enhanced survival of patients. These include addition of new chemotherapy drugs, other targeted agents such as Bevacizumab, Cetuximab, etc and radiation fractionation. The rationale for using neoadjuvant chemotherapy is that a reduction in the overall tumor burden will permit more effective local therapy and reduce the rates of distant metastases. Neoadjuvant cisplatin / docetaxel are active agents for locally advanced nasopharyngeal cancer. The addition of docetaxel to platinum containing neoadjuvant chemotherapy in other locally advanced head and neck squamous-cell carcinoma have also been shown to improve survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Chemo+RT low dose | Experimental | Combination Product: Chemo + Low dose RT, Drug: Chemo aloneChemo + Low dose RT: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin (CDDP) 75mg/m2 IV D1 and radiation therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for a total of 2 cycles every 21 days. |
| B: Chemo alone | Active comparator | Combination Product: Chemo + Low dose RT, Drug: Chemo aloneChemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- WHO II-III carcinoma of the nasopharynx, histologically proven.
- Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases.
- Age between 18 and 70 years.
- ECOG performance status 0-2.
- Hematological function parameters performed within 10 days before inclusion:
Key exclusion criteria (14 listed)
- Patients who present stage I, IIa, IIb and IVc.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies.
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 |
|---|---|---|
| Chemo + Low dose RTAlso: Chemotherapy, Low Dose Radiation TherapyIntervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days. | Combination product | A: Chemo+RT low dose, B: Chemo alone |
| Chemo aloneAlso: ChemotherapyChemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days. | Drug | A: Chemo+RT low dose, B: Chemo alone |
Primary outcome
Evaluation of chemo and radiation toxicities
Time frame: Three years
Chemotherapy and acute radiation toxicities as evaluated using the revised NCI (CTCAE) Version 4.03
1 secondary outcome
Distant and loco regional failure
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal Cancer
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
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Nasser Alrajhi, MD principal investigator
King Faisal Specialist Hospital & Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemo + Low dose RT and Chemo alone in people with Nasopharyngeal Cancer, run by King Faisal Specialist Hospital & Research Center.
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 14 inclusion and 14 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 26 Mar 2019. 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?
Results are not available in the source record.
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?
Evaluation of chemo and radiation toxicities (time frame: Three 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 26 Mar 2019.