Carcinoma, NasopharyngealEARNNCT04538547
Randomized Trial to Evaluate Accelerated Radiotherapy in Locally Advanced Carcinoma of Nasopharynx
A study testing Accelerated Radiotherapy and Non Accelerated Radiotherapy in people with Carcinoma, Nasopharyngeal, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The present study is designed as a two arm randomized trial to evaluate the impact of accelerated radiotherapy delivered by image guided radiotherapy with rapid arc technique in carcinoma nasopharynx. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Carcinoma, Nasopharyngeal
- What is being tested?
- Accelerated Radiotherapy and Non Accelerated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 16 Sep 2019to Sep 2022
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histopathologically proven non keratinizing nasopharangeal cancers.
- Karnofsky performance status more than 70
- Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- Patients willing for informed consent and regular follow up
Who cannot join
- Keratinizing squamous cell carcinoma
- Age >70 years
- Patients who have received previous chemoradiotherapy.
- Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
Trial locations and contacts
1 site in 1 country.
ANURAG VERMA, MSc contact
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
AMIT BAHL, MD, +916283774431, dramtbahl@yahoo.com
About this study
Official title: Randomized Trial to Evaluate Accelerated Radiotherapy in the Management of Locally Advanced Carcinoma of Nasopharynx Using Rapid Arc Image Guided Radiotherapy
The present study is designed as a two arm randomized trial to evaluate the impact of accelerated radiotherapy delivered by image guided radiotherapy with rapid arc technique in carcinoma nasopharynx. The study will evaluate a pure acceleration schedule of 6 fractions per week with concurrent chemotherapy and without any radiotherapy dose escalation.The control arm will receive standard chemoradiotherapy using image guided radiotherapy with rapid arc technique.
Read the detailed description
The study is designed as a two arm prospective randomized controlled trial which will be carried out in the Department of Radiotherapy and Otolaryngology at PGIMER, Chandigarh.
Inclusion criteria
- Histopathologically proven non keratinizing nasopharangeal cancers.
- Karnofsky performance status more than 70
- Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- Patients willing for informed consent and regular follow up
Exclusion Criteria
- Keratinizing squamous cell carcinoma
- Age >70 years
- Patients who have received previous chemoradiotherapy.
- Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
Randomization Patients will be randomized into the two study groups using computer generated randomization table given below.Total number of patients to be recruited will be 120 and will be divided into • Study Group A (N= 60): Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday
- Control Group B (N=60) : Concurrent Chemoradiotherapy followed by 3 cycles adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday.
Treatment Protocol Clinical evaluation All patients enrolled in the study will undergo a full clinical examination including a complete head and neck check up Investigations All patients enrolled in the study will undergo the following investigations
- Complete Haemogram, Liver Function test \& Kidney Function Tests, Blood Sugar
- Chest X Ray PA View
- X Ray Soft tissue neck
- ECG
- CECT Head and Neck/ Contrast enhanced MRI head and neck
- Biopsy from primary tumor and FNAC from neck nodes
RADIOTHERAPY Chemoradiotherapy treatment protocol For radiotherapy planning patients will be immobilized using S type thermoplastic cast \& will undergo a planning CT scan with 3mm slice thickness. The images will be transferred to Eclipse treatment planning system. All patients will be planned with 6MV photons using 4 arcs with SIB Rapid Arc technique using the dose prescription given below.
PTV70: 70 Gy in 33 fractions PTV59.4 : 59.4 Gy in 33 fractions PTV50.4: 54 Gy in 33fractions Concurrent chemotherapy will be given using Cisplatin injection 40mg/m.sq weekly or 100mg/m.sq 3 weekly along with radiotherapy in both the groups. Patients will undergo will undergo a repeat treatment planning CT scan at the 16th radiotherapy fraction and will be evaluated for adaptive re-planning.
CHEMOTHERAPY Concurrent : Inj. CDDP 100mg/m2 D1 q 3weekly along with XRT
Adjuvant:
Inj. CDDP 80mg/ m2 D1 q 3 weekly x 3 cycles Inj. 5- FU 1gm/ m2 D1-4
Patients weight will be monitored weekly during treatment.patients will be reviewed at 16th fraction of treatment. Patients with a weight loss more than 10 % or a decrease of neck diameter by more than 10% will be evaluated for need for adaptive re-planning.Where indicated patients will be replanned .
Toxicity \& Response Evaluation Patients will be evlautaed weekly for dermatological, mucositis,Dysphagia, haemtological ,gastrointestinal \& constitutional toxicity using Common Terminology Criteria for adverse effects (CTCAE v3). Overall Response will be evaluated at end of treatment using Response evaluation criteria for solid Tumors (RECIST ).
Follow up All patients included in the study will be followed up 2 monthly intervals during the first year, at 3 monthly intervals during the 2-3 years and 6 monthly intervals thereafter. At each visit a full clinical examination, toxicity grading and disease status will be evaluated.
Statistics Assuming a significance level of 0.05 and power of 80% a minimum of 110 patients need to be recruited to detect a difference of about 25% in failure free survival including a drop out rate of 10%.For statistical analysis data will be entered into SPSSv 20.Treatment toxicity will be compared between the treatment groups using independent 't' test. Pearson correlation test and logistic regression analysis will be used to evaluate prognostic variables.Survival analysis will be done using Kaplan Meir analysis. A p value <0.05 will be considered as statistically significant.
- Conditions
- Carcinoma, Nasopharyngeal
- Being tested
- Accelerated Radiotherapy, Non Accelerated Radiotherapy
- Keywords
- altered fractionation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated RadiotherapyRadiation
Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday
Non Accelerated RadiotherapyRadiation
Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Radiotherapy | Experimental | Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday Receives: Radiation: Accelerated Radiotherapy |
| Non Accelerated Radiotherapy | Active comparator | Concurrent Chemoradiotherapy followed by 3 cycles adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday. Receives: Radiation: Non Accelerated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare acute treatment related toxicity between the two study groups
Patients under study will be monitored for acute toxicity using CTCAEv3
Measured: Within 90 days of completion of treatment
To compare overall response rates between the two study group
Overall survival will be compared between the study and control group at end of study
Measured: At 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start16 Sep 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, NasopharyngealStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, AMIT BAHL, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- AMIT BAHL, MD, Principal investigator, PGIMER CHANDIGARH INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538547
- Sponsor's protocol ID
- IEC-02/2019-1122
- Acronym
- EARN
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AW, Sze WM, Yau TK, Yeung RM, Chappell R, Fowler JF. Retrospective analysis on treating nasopharyngeal carcinoma with accelerated fractionation (6 fractions per week) in comparison with conventional fractionation (5 fractions per week): report on 3-year tumor control and normal tissue toxicity. Radiother Oncol. 2001 Feb;58(2):121-30. doi: 10.1016/s0167-8140(00)00312-1.
PubMed 11166862Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
PubMed 25957714Lacas B, Bourhis J, Overgaard J, Zhang Q, Gregoire V, Nankivell M, Zackrisson B, Szutkowski Z, Suwinski R, Poulsen M, O'Sullivan B, Corvo R, Laskar SG, Fallai C, Yamazaki H, Dobrowsky W, Cho KH, Beadle B, Langendijk JA, Viegas CMP, Hay J, Lotayef M, Parmar MKB, Auperin A, van Herpen C, Maingon P, Trotti AM, Grau C, Pignon JP, Blanchard P; MARCH Collaborative Group. Role of radiotherapy fractionation in head and neck cancers (MARCH): an updated meta-analysis. Lancet Oncol. 2017 Sep;18(9):1221-1237. doi: 10.1016/S1470-2045(17)30458-8. Epub 2017 Jul 27.
PubMed 28757375
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate Accelerated Radiotherapy in the Management of Locally Advanced Carcinoma of Nasopharynx Using Rapid Arc Image Guided Radiotherapy
- ClinicalTrials.gov ID
- NCT04538547
- Acronym / sponsor ID
- EARN / IEC-02/2019-1122
- Conditions
- Carcinoma, Nasopharyngeal
- Keywords
- altered fractionation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 4 Sep 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.
The present study is designed as a two arm randomized trial to evaluate the impact of accelerated radiotherapy delivered by image guided radiotherapy with rapid arc technique in carcinoma nasopharynx. The study will evaluate a pure acceleration schedule of 6 fractions per week with concurrent chemotherapy and without any radiotherapy dose escalation.The control arm will receive standard chemoradiotherapy using image guided radiotherapy with rapid arc technique.
Detailed description
The study is designed as a two arm prospective randomized controlled trial which will be carried out in the Department of Radiotherapy and Otolaryngology at PGIMER, Chandigarh.
Inclusion criteria
- Histopathologically proven non keratinizing nasopharangeal cancers.
- Karnofsky performance status more than 70
- Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- Patients willing for informed consent and regular follow up
Exclusion Criteria
- Keratinizing squamous cell carcinoma
- Age >70 years
- Patients who have received previous chemoradiotherapy.
- Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
Randomization Patients will be randomized into the two study groups using computer generated randomization table given below.Total number of patients to be recruited will be 120 and will be divided into • Study Group A (N= 60): Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday
- Control Group B (N=60) : Concurrent Chemoradiotherapy followed by 3 cycles adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday.
Treatment Protocol Clinical evaluation All patients enrolled in the study will undergo a full clinical examination including a complete head and neck check up Investigations All patients enrolled in the study will undergo the following investigations
- Complete Haemogram, Liver Function test \& Kidney Function Tests, Blood Sugar
- Chest X Ray PA View
- X Ray Soft tissue neck
- ECG
- CECT Head and Neck/ Contrast enhanced MRI head and neck
- Biopsy from primary tumor and FNAC from neck nodes
RADIOTHERAPY Chemoradiotherapy treatment protocol For radiotherapy planning patients will be immobilized using S type thermoplastic cast \& will undergo a planning CT scan with 3mm slice thickness. The images will be transferred to Eclipse treatment planning system. All patients will be planned with 6MV photons using 4 arcs with SIB Rapid Arc technique using the dose prescription given below.
PTV70: 70 Gy in 33 fractions PTV59.4 : 59.4 Gy in 33 fractions PTV50.4: 54 Gy in 33fractions Concurrent chemotherapy will be given using Cisplatin injection 40mg/m.sq weekly or 100mg/m.sq 3 weekly along with radiotherapy in both the groups. Patients will undergo will undergo a repeat treatment planning CT scan at the 16th radiotherapy fraction and will be evaluated for adaptive re-planning.
CHEMOTHERAPY Concurrent : Inj. CDDP 100mg/m2 D1 q 3weekly along with XRT
Adjuvant:
Inj. CDDP 80mg/ m2 D1 q 3 weekly x 3 cycles Inj. 5- FU 1gm/ m2 D1-4
Patients weight will be monitored weekly during treatment.patients will be reviewed at 16th fraction of treatment. Patients with a weight loss more than 10 % or a decrease of neck diameter by more than 10% will be evaluated for need for adaptive re-planning.Where indicated patients will be replanned .
Toxicity \& Response Evaluation Patients will be evlautaed weekly for dermatological, mucositis,Dysphagia, haemtological ,gastrointestinal \& constitutional toxicity using Common Terminology Criteria for adverse effects (CTCAE v3). Overall Response will be evaluated at end of treatment using Response evaluation criteria for solid Tumors (RECIST ).
Follow up All patients included in the study will be followed up 2 monthly intervals during the first year, at 3 monthly intervals during the 2-3 years and 6 monthly intervals thereafter. At each visit a full clinical examination, toxicity grading and disease status will be evaluated.
Statistics Assuming a significance level of 0.05 and power of 80% a minimum of 110 patients need to be recruited to detect a difference of about 25% in failure free survival including a drop out rate of 10%.For statistical analysis data will be entered into SPSSv 20.Treatment toxicity will be compared between the treatment groups using independent 't' test. Pearson correlation test and logistic regression analysis will be used to evaluate prognostic variables.Survival analysis will be done using Kaplan Meir analysis. A p value <0.05 will be considered as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Radiotherapy | Experimental | Radiation: Accelerated RadiotherapyAccelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday |
| Non Accelerated Radiotherapy | Active comparator | Radiation: Non Accelerated RadiotherapyConcurrent Chemoradiotherapy followed by 3 cycles adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathologically proven non keratinizing nasopharangeal cancers.
- Karnofsky performance status more than 70
- Stage T3-4, N0-3 patients (as per AJCC 8th edition).
- Patients willing for informed consent and regular follow up
Key exclusion criteria (4 listed)
- Keratinizing squamous cell carcinoma
- Age >70 years
- Patients who have received previous chemoradiotherapy.
- Patients with uncontrolled co- morbid conditions like hypertension , diabetes or any renal impairment
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 |
|---|---|---|
| Accelerated RadiotherapyAccelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday | Radiation | Accelerated Radiotherapy |
| Non Accelerated RadiotherapyChemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday | Radiation | Non Accelerated Radiotherapy |
Primary outcome
To compare acute treatment related toxicity between the two study groups
Time frame: Within 90 days of completion of treatment
Patients under study will be monitored for acute toxicity using CTCAEv3
To compare overall response rates between the two study group
Time frame: At 1 year follow up
Overall survival will be compared between the study and control group at end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 11166862Lee AW, Sze WM, Yau TK, Yeung RM, Chappell R, Fowler JF. Retrospective analysis on treating nasopharyngeal carcinoma with accelerated fractionation (6 fractions per week) in comparison with conventional fractionation (5 fractions per week): report on 3-year tumor control and normal tissue toxicity. Radiother Oncol. 2001 Feb;58(2):121-30. doi: 10.1016/s0167-8140(00)00312-1.
- Background: PubMed 25957714Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
- Background: PubMed 28757375Lacas B, Bourhis J, Overgaard J, Zhang Q, Gregoire V, Nankivell M, Zackrisson B, Szutkowski Z, Suwinski R, Poulsen M, O'Sullivan B, Corvo R, Laskar SG, Fallai C, Yamazaki H, Dobrowsky W, Cho KH, Beadle B, Langendijk JA, Viegas CMP, Hay J, Lotayef M, Parmar MKB, Auperin A, van Herpen C, Maingon P, Trotti AM, Grau C, Pignon JP, Blanchard P; MARCH Collaborative Group. Role of radiotherapy fractionation in head and neck cancers (MARCH): an updated meta-analysis. Lancet Oncol. 2017 Sep;18(9):1221-1237. doi: 10.1016/S1470-2045(17)30458-8. Epub 2017 Jul 27.
- Individual participant dataSharing planned: No
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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.
ANURAG VERMA, MSc contact
AMIT BAHL, MD principal investigator
PGIMER CHANDIGARH INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Radiotherapy and Non Accelerated Radiotherapy in people with Carcinoma, Nasopharyngeal, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 inclusion and 4 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 4 Sep 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 India. 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.
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 AMIT BAHL, MD (+916283774431, dramitbahl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare acute treatment related toxicity between the two study groups (time frame: Within 90 days of completion of treatment). The study lists 2 primary outcomes in all. 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 NCT04538547, which also lists 3 linked publications.
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 4 Sep 2020.