A study comparing radiotherapy alone versus radiotherapy combined with chemotherapy after surgery in patients with intermediate-risk oral cavity cancer.

Intermediate-risk resected oral-cavity adjuvant radiotherapy vs concurrenT chemoradiotherapy - INTERACT-OC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112856

Enrollment

270

Registered

2026-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: C030- Malignant neoplasm of upper gum Health Condition 2: C031- Malignant neoplasm of lower gum Health Condition 3: C050- Malignant neoplasm of hard palate Health Condition 4: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 5: C021- Malignant neoplasm of border of tongue Health Condition 6: C022- Malignant neoplasm of ventral surface of tongue Health Condition 7: C003- Malignant neoplasm of upper lip, inner aspect Health Condition 8: C004- Malignant neop

Interventions

Intervention1: Weekly concurrent chemotherapy with radiotherapy.: Weekly concurrent cisplatin (40 mg/m ) for 6 weeks. In case of non-availability of cisplatin, inj. docetaxel (15 mg/m ) is to be used.

54 Gy/30 fx to elective CTVs as indicated via SIB technique Targeting: ICRU reporting

nodal levels per consensus atlases

OC primaries typically include appropriate ipsilateral levels I III with tailored inclusion of IV/V based on pathological risk.

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 or more to less than 70 years, Performance status 0 to 2, willing to provide informed written consent. Histologically confirmed oral cavity Squamous Cell Carcinoma (lips, oral tongue, floor of mouth, buccal mucosa, alveolar ridge, hard palate, Retromolar trigone). One or more intermediate-risk factors: pT3 or pT4a; LVSI; PNI; close margin 5 mm or less; 1 or more positive nodes in level IV or V, N2b or N2C. Adequate marrow (absolute neutrophil count 1500 /uL or more, platelets 100000 cells/uL or more), renal (creatinine clearance 60 mL/min or more), and hepatic (bilirubin 1.5 times ULN or less, AST/ALT 2.5 times ULN or less).

Exclusion criteria

Exclusion criteria: Positive margin or Extranodal extension, prior Radiotherapy or chemo for index cancer, and distant metastasis Significant comorbidities precluding cisplatin or RT (for example, uncontrolled cardiac disease, baseline hearing loss grade 2 or more, neuropathy grade 2 or more) Pregnancy or lactation; other active invasive malignancy within 5 years (except cured NMSC/cervical in situ)

Design outcomes

Primary

Measure	Time frame
Progression-free survival Locoregional control Acute toxicity Quality of Life Secondary outcome: Overall Survival Late toxicitiesTimepoint: Preplanned interim Analysis at 50% PFS events Final analysis at the end of 6 years	—

Secondary

Measure	Time frame
Overall Survival Late toxicities Timepoint: Preplanned interim Analysis at 50% PFS events Final analysis at the end of 6 years	—

Countries

India

Contacts

Public ContactAnkita Singh

Amrita Institute of Medical Sciences

drsinghankita31@gmail.com08826480829

Outcome results

None listed

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