Exploring New Radiotherapy Schedule In Oral Cancer: A Phase 1 study

Commencement of Hypofractionated Adjuvant Radiotherapy in Intermediate risk Oral cavity cancer: A Phase 1 study. - CHARIOT -1

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073386

Enrollment

Registered

2024-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: C031- Malignant neoplasm of lower gum Health Condition 2: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 3: C029- Malignant neoplasm of tongue, unspecified Health Condition 4: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: Hypofractionated Adjuvant Radiotherapy(HFRT): Study will be carried out in 2 parts: Part A:Various HFRT schedules in treatment escalation manner will be evaluated to find out maximum t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: between 18-60 years. 2. Having undergone multi-disciplinary decision regarding need for adjuvant RT. 3. Those who provide willingness to consent for participation in trial and follow up.

Exclusion criteria

Exclusion criteria: 1. Patients having PS 2 or more 2. Patients who had received neo-adjuvant chemotherapy prior to radical surgery. 3. Having any pathological high-risk criteria, such as Pathologically positive resection margin or Pathologically positive cervical node with ECE 4. Patients having residual disease post primary surgery. 5. Patients with hard palate primary 6. Post surgery feeding tube dependency 7. Previous history of RT to face and neck 8. Having metastatic disease 9. Having recurrent disease 10. Having connective tissue disorders 11. Medical or psychological illness precluding treatment protocol 12. pregnant and breast feeding women 13. Patients with high density or metallic prosthesis inside treatment volumes affecting RT dose calculation

Design outcomes

Primary

Measure	Time frame
Tolerability of moderate HFRT in post-operative OSCC patients by establishing the maximum tolerable dose and fractionation (MTDF).Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Acute toxicities of adjuvant HFRT.Timepoint: 12 weeks;Consequential and late toxicities of HFRT.Timepoint: 3 years;Quality of life of patients receiving HFRTTimepoint: 3 years	—

Countries

India

Contacts

Public ContactDr Rohit Avinash Vadgaonkar

Homi Bhabha Cancer Hospital and Research Centre

mansi.chandwani15@gmail.com919131463419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026