Skip to content

Testing higher radiation doses guided by PETCT scans for advanced head and neck cancer

An interventional study to assess dosimetric feasibility and tolerability of 18-FDG PETCT guided dose escalation in locally advanced head and neck squamous cell carcinoma - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085147
Enrollment
20
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C04- Malignant neoplasm of floor of mouth Health Condition 3: C13- Malignant neoplasm of hypopharynx Health Condition 4: C00- Malignant neoplasm of lip Health Condition 5: C10- Malignant neoplasm of oropharynx Health Condition 6: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Health Condition 7: C02- Malignant neoplasm of other and unspecified parts of tongue Health Condi

Interventions

Intervention1: Dose escalation using PETCT: To check the feasibility and tolerability of dose escalation using PETCT Duration of intervention is 6 weeks Control Intervention1: conventional chemo radi

Sponsors

Dr Naga Sireesha Kalla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-70 yrs 2.Biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx and larynx 3.Human Papilloma virus (HPV) negative status 4.Stage III/IVA/IVB, T3-4, N0-3, M0 5.Creatinine clearance greater than 60 ml 6.ECOG PS 0 to 1 7.No previous malignancies 8.Adequate bone marrow function, adequate hepatic function 9.Written informed consent 10.Able to comply with follow up

Exclusion criteria

Exclusion criteria: 1.Presence of distant metastases (AJCC stage IVC) 2.Previous radiotherapy in the head and neck region 3.Prior surgery, radiotherapy or chemotherapy for this tumor 4.Nasopharyngeal and para nasal sinus malignancies 5.HPV positive status 6.Patients who are not suitable for chemo-radiotherapy 7.Refusal of the patients to take part in the trial

Design outcomes

Primary

MeasureTime frame
feasibility and tolerability of dose escalation with PETCTTimepoint: During the course of treatment or intervention

Secondary

MeasureTime frame
acute & late toxicities associated with dose escalationTimepoint: At baseline,6 weeks & 3 months

Countries

India

Contacts

Public ContactDr Ajay Kumar Kondenti

AIIMS, Mangalagiri

ajay.rt@aiimsmangalagiri.edu.in7989599004

Outcome results

None listed

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