Use of radiation treatment after surgery for small Oral cancers.

Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) â?? a prospective randomized control trial - AREST

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009114

Enrollment

392

Registered

2017-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Early stage oral tongue cancers Health Condition 2: C03- Malignant neoplasm of gum Health Condition 3: C04- Malignant neoplasm of floor of mouth Health Condition 4: C02- Malignant neoplasm of other and unspecified parts of tongue

Interventions

Intervention1: Group II: Study arm (Post-operative adjuvant radiotherapy): Intervention in the study group (Group II) will be in the form of post-operative adjuvant radiotherapy starting within 8-week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post-operative early stage squamous cell carcinoma of oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition. pT2 is defined in AJCC 8th edition as i. Tumor 5mm and â?¤ 10mm. ii. Tumor > 2cm but â?¤ 4cm and depth of invasion (DOI) â?¤ 10mm.) 2. Adequate surgery (Defined as wide local excision of primary tumor with tumor free margin â?¥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.) 3. Written informed consent. 4. Age â?¥18 years 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 6. Depth of invasion (DOI) â?¥ 5 mm. 7. Compliance to therapy and follow-up 8. Interval from surgery to adjuvant radiotherapy â?¤ 8 weeks

Exclusion criteria

Exclusion criteria: 1. pT3/pT4 (as specified in the AJCC 8th edition). 2. Depth of invasion 3. Any neck nodal metastasis with or without extra nodal extension. 4. Tumor free margin 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. 9. Presence of HIV infection

Design outcomes

Primary

Measure	Time frame
Loco-regional recurrence free survivalTimepoint: Three years from the date of surgery for the index lesion.	—

Secondary

Measure	Time frame
Overall survivalTimepoint: Date of Randomization to date of death from any cause;Disease free survivalTimepoint: Calculated as difference of date of randomization to date of first recurrence or relapse, second primary or death;Quality of life with on (EORTC QLQ H&N-35) and EORTC QLQ-C 30Timepoint: First before starting RT and subsequently every three months after RT.;Acute and long-term Radiation toxicity rate with CTCAE v5.0Timepoint: At 3 monthly regular follow up interval	—

Measure

Time frame

Overall survivalTimepoint: Date of Randomization to date of death from any cause;Disease free survivalTimepoint: Calculated as difference of date of randomization to date of first recurrence or relapse, second primary or death;Quality of life with on (EORTC QLQ H&N-35) and EORTC QLQ-C 30Timepoint: First before starting RT and subsequently every three months after RT.;Acute and long-term Radiation toxicity rate with CTCAE v5.0Timepoint: At 3 monthly regular follow up interval

—

Countries

India

Contacts

Public ContactDr Sudhir V Nair

Tata Memorial Center

sudhirvr@gmail.com9769617780

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 29, 2026