Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538547
Status:
UNKNOWN
Last Update Posted:
2020-09-04
First Post:
2020-08-30
Brief Title:
Randomized Trial to Evaluate Accelerated Radiotherapy in Locally Advanced Carcinoma of Nasopharynx
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Randomized Trial to Evaluate Accelerated Radiotherapy in the Management of Locally Advanced Carcinoma of Nasopharynx Using Rapid Arc Image Guided Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARN
Brief 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 The study will evaluate a pure acceleration schedule of 6 fractions per week with concurrent chemotherapy and without any radiotherapy dose escalationThe 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
1 Histopathologically proven non keratinizing nasopharangeal cancers
2 Karnofsky performance status more than 70
3 Stage T3-4 N0-3 patients as per AJCC 8th edition
4 Patients willing for informed consent and regular follow up
Exclusion Criteria
1 Keratinizing squamous cell carcinoma
2 Age 70 years
3 Patients who have received previous chemoradiotherapy
4 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 belowTotal 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 N60 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
1 Complete Haemogram Liver Function test Kidney Function Tests Blood Sugar
2 Chest X Ray PA View
3 X Ray Soft tissue neck
4 ECG
5 CECT Head and Neck Contrast enhanced MRI head and neck
6 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 PTV594 594 Gy in 33 fractions PTV504 54 Gy in 33fractions Concurrent chemotherapy will be given using Cisplatin injection 40mgmsq weekly or 100mgmsq 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 100mgm2 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 treatmentpatients 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-planningWhere indicated patients will be replanned
Toxicity Response Evaluation Patients will be evlautaed weekly for dermatological mucositisDysphagia 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 005 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 10For statistical analysis data will be entered into SPSSv 20Treatment 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 variablesSurvival analysis will be done using Kaplan Meir analysis A p value 005 will be considered as statistically significant
Inclusion criteria
1 Histopathologically proven non keratinizing nasopharangeal cancers
2 Karnofsky performance status more than 70
3 Stage T3-4 N0-3 patients as per AJCC 8th edition
4 Patients willing for informed consent and regular follow up
Exclusion Criteria
1 Keratinizing squamous cell carcinoma
2 Age 70 years
3 Patients who have received previous chemoradiotherapy
4 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 belowTotal 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 N60 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
1 Complete Haemogram Liver Function test Kidney Function Tests Blood Sugar
2 Chest X Ray PA View
3 X Ray Soft tissue neck
4 ECG
5 CECT Head and Neck Contrast enhanced MRI head and neck
6 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 PTV594 594 Gy in 33 fractions PTV504 54 Gy in 33fractions Concurrent chemotherapy will be given using Cisplatin injection 40mgmsq weekly or 100mgmsq 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 100mgm2 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 treatmentpatients 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-planningWhere indicated patients will be replanned
Toxicity Response Evaluation Patients will be evlautaed weekly for dermatological mucositisDysphagia 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 005 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 10For statistical analysis data will be entered into SPSSv 20Treatment 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 variablesSurvival analysis will be done using Kaplan Meir analysis A p value 005 will be considered as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None