Condition or disease | Intervention/treatment | Phase |
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Cancer of Mouth Cancer of the Tongue Cancer of the Head and Neck Buccal Mucosa Cancer Floor of Mouth Carcinoma | Radiation: Post-operative adjuvant radiotherapy | Not Applicable |
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal to 5mm.
Primary objective:
To determine the impact of postoperative adjuvant radiotherapy on locoregional recurrence-free survival in patients with early-stage oral tongue cancer with tumor thickness ≥ 5 mm.
Secondary objectives:
We will be conducting a Phase III Open-Label Prospective Randomized Controlled Trial using stratified randomization. Patients will be randomized into two groups:
Group I: Control arm (Observation only) Group II: Study arm (Postoperative adjuvant radiotherapy)
Patients will be stratified on the following factors
Study procedures:
The study population will consist of patients who have been treated by surgery for early-stage oral cancers. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. The depth of invasion will be assessed microscopically by measuring the maximum vertical bulk of the tumor from the normal mucosal surface to the deepest point of invasion. After reviewing the histopathological report, patients will be randomized to one of the 2 arms. Patients belonging to study arm (Group II) will receive adjuvant radiotherapy 60 Gray, 30 fractions for 30 days over 6 weeks as routinely prescribed at Tata Memorial Center (TMC) and will receive the treatment within or by 6 weeks after surgery.
Both the groups (Group I and Group II) will be under regular follow-up with 3 monthly intervals for the first 2 years and 6 monthly for the next 3 years and once a year thereafter. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of randomization and the date of biopsy-proven recurrence. We will also record the overall survival in both groups. The quality of life will be assessed at each follow-up regular intervals using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ H&N-35 ) and EORTC QLQ-C 30. The radiation toxicity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 392 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) |
Actual Study Start Date : | August 2, 2018 |
Estimated Primary Completion Date : | August 1, 2022 |
Estimated Study Completion Date : | September 30, 2025 |
Arm | Intervention/treatment |
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No Intervention: Control arm
Patients in this arm will be observed and kept under active follow-up after surgery for the primary.
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Experimental: Study arm
Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery.
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Radiation: Post-operative adjuvant radiotherapy
Conventional treatment planning, as well as intensity-modulated radiation therapy (IMRT) planning, would be allowed on the study with patients being stratified on the RT technique. Treatment would be delivered on telecobalt unit (gamma-rays/linear accelerator (6MV photons). All fields would be treated daily. Phase I: 46 Gray(Gy) in 23 fractions over 4.5 weeks Phase II: 14Gray in 7 fractions over 1.5 weeks For IMRT, inverse planning would be done on a commercial TPS configured to deliver IMRT using 6MV photons. Patients shall be treated using the simultaneous integrated boost (SIB) technique with 5 fractions being delivered every week. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sudhir V Nair, MS, MCh | 912224177283 | sudhirvr@gmail.com | |
Contact: Tejpal Gupta, MD | 919821548980 | tejpalgupta@rediffmail.com |
India | |
Dr. B Barooah Cancer Institute | Recruiting |
Guwahati, Assam, India, 781016 | |
Contact: Ashok Das, MS akdas171@gmail.com | |
HCG Hospital | Recruiting |
Ahmedabad, Gujarat, India, 380006 | |
Contact: Rajendra Toprani, MCh rajendratoprani@hotmail.com | |
Mazumdar Shaw Medical Centre | Recruiting |
Bangalore, Karnataka, India, 560100 | |
Contact: Narayana Subramaniam, MS, MCh narayana.subramaniam@gmail.com | |
Principal Investigator: Narayana Subramaniam, MS,MCh | |
Sub-Investigator: Naveen H Chandrasekhar, MS,MCh | |
Sub-Investigator: Sandeep Jain, MD | |
Amrita Institute of Medical Sciences | Recruiting |
Kochi, Kerala, India, 682041 | |
Contact: Subramania Iyer, MCh subu.amrita@gmail.com | |
Principal Investigator: Subramania Iyer, MS, MCh | |
Tata Memorial Centre | Recruiting |
Mumbai, Maharashtra, India, 400012 | |
Contact: Sudhir V Nair, MBBS, MS 912224177000 ext 7283 sudhirvr@gmail.com | |
Contact: Tejpal Gupta, MBBS, MD 919821548980 tejpalgupta@rediffmail.com | |
Principal Investigator: Sudhir V Nair, MS,MCh | |
Sub-Investigator: Tejpal Gupta, MD | |
Sub-Investigator: Sarbani Laskar, MD | |
Sub-Investigator: Pankaj Chaturvedi, MS | |
Sub-Investigator: Devendra Chaukar, MS | |
Sub-Investigator: Anil K D'Cruz, MS,FRCS | |
Cancer Institute Adyar | Not yet recruiting |
Adyar, Tamil Nadu, India, 600020 | |
Contact: Arvind Krishnamurthy, MS, MCh drarvindkrishnamurthy@gmail.com |
Principal Investigator: | Sudhir V Nair, MS, MCh | Associate Professor |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 20, 2017 | ||||||||
First Posted Date ICMJE | February 25, 2019 | ||||||||
Last Update Posted Date | March 11, 2020 | ||||||||
Actual Study Start Date ICMJE | August 2, 2018 | ||||||||
Estimated Primary Completion Date | August 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
loco-regional recurrence free survival [ Time Frame: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant. ] Measures the number of local or regional recurrences in both arm over a defined time frame.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Adjuvant Radiotherapy in Early Stage Oral Cancers | ||||||||
Official Title ICMJE | Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) | ||||||||
Brief Summary | This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Patients with a close or positive margin (</= 5mm) and or with metastatic neck node(s) will be excluded. Selected patients will be randomized into two groups. The group I will be observed after surgery and group II will receive adjuvant radiotherapy as per protocol. | ||||||||
Detailed Description |
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal to 5mm. Primary objective: To determine the impact of postoperative adjuvant radiotherapy on locoregional recurrence-free survival in patients with early-stage oral tongue cancer with tumor thickness ≥ 5 mm. Secondary objectives:
We will be conducting a Phase III Open-Label Prospective Randomized Controlled Trial using stratified randomization. Patients will be randomized into two groups: Group I: Control arm (Observation only) Group II: Study arm (Postoperative adjuvant radiotherapy) Patients will be stratified on the following factors
Study procedures: The study population will consist of patients who have been treated by surgery for early-stage oral cancers. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. The depth of invasion will be assessed microscopically by measuring the maximum vertical bulk of the tumor from the normal mucosal surface to the deepest point of invasion. After reviewing the histopathological report, patients will be randomized to one of the 2 arms. Patients belonging to study arm (Group II) will receive adjuvant radiotherapy 60 Gray, 30 fractions for 30 days over 6 weeks as routinely prescribed at Tata Memorial Center (TMC) and will receive the treatment within or by 6 weeks after surgery. Both the groups (Group I and Group II) will be under regular follow-up with 3 monthly intervals for the first 2 years and 6 monthly for the next 3 years and once a year thereafter. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of randomization and the date of biopsy-proven recurrence. We will also record the overall survival in both groups. The quality of life will be assessed at each follow-up regular intervals using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ H&N-35 ) and EORTC QLQ-C 30. The radiation toxicity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Radiation: Post-operative adjuvant radiotherapy
Conventional treatment planning, as well as intensity-modulated radiation therapy (IMRT) planning, would be allowed on the study with patients being stratified on the RT technique. Treatment would be delivered on telecobalt unit (gamma-rays/linear accelerator (6MV photons). All fields would be treated daily. Phase I: 46 Gray(Gy) in 23 fractions over 4.5 weeks Phase II: 14Gray in 7 fractions over 1.5 weeks For IMRT, inverse planning would be done on a commercial TPS configured to deliver IMRT using 6MV photons. Patients shall be treated using the simultaneous integrated boost (SIB) technique with 5 fractions being delivered every week. |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
392 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 30, 2025 | ||||||||
Estimated Primary Completion Date | August 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | India | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03853655 | ||||||||
Other Study ID Numbers ICMJE | 1713 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dr. Sudhir Nair, Tata Memorial Hospital | ||||||||
Study Sponsor ICMJE | Tata Memorial Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Tata Memorial Hospital | ||||||||
Verification Date | March 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |