Randomized Trial to Evaluate Accelerated Radiotherapy in Locally Advanced Carcinoma of Nasopharynx
EARN
1 other identifier
interventional
120
1 country
1
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 escalation.The control arm will receive standard chemoradiotherapy using image guided radiotherapy with rapid arc technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2019
CompletedFirst Submitted
Initial submission to the registry
August 30, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 4, 2020
August 1, 2020
3 years
August 30, 2020
August 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To compare acute treatment related toxicity between the two study groups
Patients under study will be monitored for acute toxicity using CTCAEv3
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
At 1 year follow up
Study Arms (2)
Accelerated Radiotherapy
EXPERIMENTALAccelerated 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 COMPARATORConcurrent Chemoradiotherapy followed by 3 cycles adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday.
Interventions
Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday
Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
Related Publications (3)
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.
PMID: 11166862BACKGROUNDBlanchard 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.
PMID: 25957714BACKGROUNDLacas 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.
PMID: 28757375BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AMIT BAHL, MD
PGIMER CHANDIGARH INDIA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ADDITIONAL PROFESSOR
Study Record Dates
First Submitted
August 30, 2020
First Posted
September 4, 2020
Study Start
September 16, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
September 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share