Study Results
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Basic Information
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COMPLETED
NA
392 participants
INTERVENTIONAL
2018-08-02
2025-12-15
Brief Summary
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Detailed Description
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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:
1. To compare disease-free survival and overall survival between the two groups.
2. To assess and compare the quality of life changes between the two groups.
3. To assess the acute and long-term radiation toxicity.
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
1. Presence of Perineural Invasion (PNI)/Lympho-Vascular Emboli (LVE)
2. Histological grade (well-differentiated/moderately differentiated vs poorly differentiated)
3. Tongue/Floor of Mouth vs Buccal Mucosa.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm
Patients in this arm will be observed and kept under active follow-up after surgery for the primary.
No interventions assigned to this group
Study arm
Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Adequate surgery (Defined as wide local excision of the primary tumor with tumor-free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
3. Written informed consent.
4. Age ≥18 years
5. Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
6. The depth of invasion (DOI) ≥ 5 mm.
7. Compliance to therapy and follow-up
8. The interval from surgery to adjuvant radiotherapy ≤ 6 weeks
Exclusion Criteria
2. Depth of invasion \< 5mm.
3. Any neck nodal metastasis with or without extra nodal extension
4. Tumor-free margin \< 5 mm
5. Non-squamous histology
6. Pregnant woman
7. Prior h/o any other malignancy in the last five years
8. Prior therapeutic irradiation of the head and neck.
18 Years
ALL
No
Sponsors
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NATIONAL CANCER GRID
UNKNOWN
Tata Memorial Hospital
OTHER_GOV
Responsible Party
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Dr. Sudhir Nair
Professor
Principal Investigators
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Sudhir V Nair, MS, MCh
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
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Dr. B Barooah Cancer Institute
Guwahati, Assam, India
HCG Hospital
Ahmedabad, Gujarat, India
Kailash Cancer Hospital and Research Centre
Goraj, Gujarat, India
Sree Sankara Cancer Hospital
Bangalore, Karnataka, India
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, India
Malabar Cancer Centre
Kannur, Kerala, India
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Tata Memorial Centre
Mumbai, Maharashtra, India
Countries
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References
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Caramello P, Giacobbi D, Savoia D. [Identification of Pneumocystis carinii in a patient dying of AIDS]. G Batteriol Virol Immunol. 1985 Jul-Dec;78(7-12):171-7. Italian.
Thiagarajan S, Nair S, Nair D, Chaturvedi P, Kane SV, Agarwal JP, D'Cruz AK. Predictors of prognosis for squamous cell carcinoma of oral tongue. J Surg Oncol. 2014 Jun;109(7):639-44. doi: 10.1002/jso.23583. Epub 2014 Mar 12.
Dequanter D, Saint-Aubin N, Paesmans M, Badr-El-Din A, Lothaire P, Andry G. [Prognostic factors in epidermoid carcinoma of the mobile tongue classified as T1-T2]. Ann Otolaryngol Chir Cervicofac. 2001 Oct;118(5):315-22. French.
Kokemueller H, Rana M, Rublack J, Eckardt A, Tavassol F, Schumann P, Lindhorst D, Ruecker M, Gellrich NC. The Hannover experience: surgical treatment of tongue cancer--a clinical retrospective evaluation over a 30 years period. Head Neck Oncol. 2011 May 21;3:27. doi: 10.1186/1758-3284-3-27.
Ganly I, Patel S, Shah J. Early stage squamous cell cancer of the oral tongue--clinicopathologic features affecting outcome. Cancer. 2012 Jan 1;118(1):101-11. doi: 10.1002/cncr.26229. Epub 2011 Jun 29.
Gonzalez-Moles MA, Esteban F, Rodriguez-Archilla A, Ruiz-Avila I, Gonzalez-Moles S. Importance of tumour thickness measurement in prognosis of tongue cancer. Oral Oncol. 2002 Jun;38(4):394-7. doi: 10.1016/s1368-8375(01)00081-1.
Huang SF, Kang CJ, Lin CY, Fan KH, Yen TC, Wang HM, Chen IH, Liao CT, Cheng AJ, Chang JT. Neck treatment of patients with early stage oral tongue cancer: comparison between observation, supraomohyoid dissection, and extended dissection. Cancer. 2008 Mar 1;112(5):1066-75. doi: 10.1002/cncr.23278.
Shim SJ, Cha J, Koom WS, Kim GE, Lee CG, Choi EC, Keum KC. Clinical outcomes for T1-2N0-1 oral tongue cancer patients underwent surgery with and without postoperative radiotherapy. Radiat Oncol. 2010 May 27;5:43. doi: 10.1186/1748-717X-5-43.
Related Links
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SEER Cancer statistics review 1975-2010. National cancer institute
Other Identifiers
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1713
Identifier Type: -
Identifier Source: org_study_id
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