Carcinoma, Nasopharyngeal Clinical Trial
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.
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 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
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 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.
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