Adjuvant Radiotherapy in Early Stage Oral Cancers

NCT03853655 | Completed DMC

• 1 other identifier: 1713
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 8

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.

Conditions

Cancer of Mouth; Cancer of the Tongue; Cancer of the Head and Neck; Buccal Mucosa Cancer; Floor of Mouth Carcinoma

Keywords

Cancer of the Mouth; Tongue cancer; Buccal Mucosa cancer; Head and Neck; Oral Cancer; Adjuvant Radiotherapy; Depth of Invasion

Outcome Measures

Primary Outcomes (1)

• loco-regional recurrence free survival

  Measures the number of local or regional recurrences in both arm over a defined 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.

Secondary Outcomes (2)

• Disease free survival

  Calculated as difference of date of randomization to date of first documented recurrence or relapse, second primary or death or at the end of 36 months after recruitment of the last participant.

• Overall survival

  Date of randomization to death from any cause or at the end of 36 months after recruitment of the last participant.

Other Outcomes (2)

• Quality of life Measurement

  at Randomization, 3 months after completion of all treatments, 1 year, 2 years and 3 years after completion of all treatments.

• Acute and long-term Radiation toxicity rate

  From the date of randomization until the date of first documented disease recurrence or date of death from any cause, assessed up to 36 months.

Study Arms (2)

Control arm

NO INTERVENTION

Patients in this arm will be observed and kept under active follow-up after surgery for the primary.

Study arm

EXPERIMENTAL

Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery.

Radiation: Post-operative adjuvant radiotherapy

Interventions

Post-operative adjuvant radiotherapy RADIATION

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.

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-operative early stage squamous cell carcinoma of the oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
• 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.)
• Written informed consent.
• Age ≥18 years
• Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
• The depth of invasion (DOI) ≥ 5 mm.
• Compliance to therapy and follow-up
• The interval from surgery to adjuvant radiotherapy ≤ 6 weeks

You may not qualify if:

• pT3/pT4 (as specified in the AJCC 8th edition).
• Depth of invasion \< 5mm.
• Any neck nodal metastasis with or without extra nodal extension
• Tumor-free margin \< 5 mm
• Non-squamous histology
• Pregnant woman
• Prior h/o any other malignancy in the last five years
• Prior therapeutic irradiation of the head and neck.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• NATIONAL CANCER GRID: collaborator

Study Sites (8)

Dr. B Barooah Cancer Institute

Guwahati, Assam, 781016, India

Location

HCG Hospital

Ahmedabad, Gujarat, 380006, India

Location

Kailash Cancer Hospital and Research Centre

Goraj, Gujarat, 391760, India

Location

Sree Sankara Cancer Hospital

Bangalore, Karnataka, 560004, India

Location

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560100, India

Location

Malabar Cancer Centre

Kannur, Kerala, 670103, India

Location

Amrita Institute of Medical Sciences

Kochi, Kerala, 682041, India

Location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

Related Publications (8)

• 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.

  PMID: 24619660 BACKGROUND

• 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.

  PMID: 11845040 BACKGROUND

• 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.

  PMID: 21600000 BACKGROUND

• 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.

  PMID: 21717431 BACKGROUND

• 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.

  PMID: 12076706 BACKGROUND

• 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.

  PMID: 18246535 BACKGROUND

• 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.

  PMID: 20504371 BACKGROUND

• 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.

  PMID: 3879892 BACKGROUND

Related Links

• SEER Cancer statistics review 1975-2010. National cancer institute

MeSH Terms

Conditions

Mouth Neoplasms; Tongue Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Sudhir V Nair, MS, MCh

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: February 25, 2019
• Study Start: August 2, 2018
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)