Using Blood Markers to Personalize Post-Surgery Treatment and Improve Outcomes for Patients with Advanced Oral Cancer

De-intensification of adjuvant therapy based on ctDNA based risk stratification in operated advanced oral squamous cell carcinoma with intermediate risk factors– A Phase III Randomised Control Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078533

Enrollment

300

Registered

2024-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: Adjuvant treatment based on ctDNA-based risk stratification: Patients in the intervention arm will receive adjuvant treatment based on ctDNA-based risk stratification to personalize the

Eligibility

Inclusion criteria

Inclusion criteria: Histological operated advanced squamous cell carcinoma of the oral cavity on final HPR Disease is Stage III or IV, with no evidence of distant metastases ECOG performance status = 2 Patients with no contraindications to Cisplatin chemotherapy Patients with no contraindications to radiotherapy Patients who can give informed consent to participate in the study. Patients who can be followed up and can take all the cycles of chemotherapy at the participating institution.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Overall SurvivalTimepoint: time of registration to time of death time of death due to disease time of death due to other causes	—

Secondary

Measure	Time frame
Disease Specific survivalTimepoint: time of registration time of clnical/radiological or pathological disease recurrence time of death due to disease;Quality of LifeTimepoint: Baseline, 3 weeks after surgery, 3 weeks after adjuvant therapy, 6 months after adjuvant therapy, 1 year after adjuvant therapy;Adverse effectsTimepoint: 3 weeks after surgery, 3 weeks after initiation of adjuvant therapy, completion of adjuvant therapy & 6 weeks after adjuvant therapy;Correlation of genetic predictors in loco regional & distant recurrencesTimepoint: ctDNA at baseline before initiation of any therapy ctDNA 3 weeks after surgery ctDNA 3 weeks after adjuvant therapy	—

Measure

Time frame

Disease Specific survivalTimepoint: time of registration time of clnical/radiological or pathological disease recurrence time of death due to disease;Quality of LifeTimepoint: Baseline, 3 weeks after surgery, 3 weeks after adjuvant therapy, 6 months after adjuvant therapy, 1 year after adjuvant therapy;Adverse effectsTimepoint: 3 weeks after surgery, 3 weeks after initiation of adjuvant therapy, completion of adjuvant therapy & 6 weeks after adjuvant therapy;Correlation of genetic predictors in loco regional & distant recurrencesTimepoint: ctDNA at baseline before initiation of any therapy ctDNA 3 weeks after surgery ctDNA 3 weeks after adjuvant therapy

—

Countries

India

Contacts

Public ContactBurhanuddin Nuruddin Qayyumi

tata memorial center

qburhan@gmail.com9566170436

Outcome results

None listed

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