Treatment outcome in head and neck cancer patients receiving carboplatin plus capecitabine based versus high dose cisplatin based chemoradiotherapy.

Concurrent chemoradiotherapy with carboplatin and capecitabine versus standard high dose cisplatin in locally advanced head and neck squamous cell cancer - CARCAP-HN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/11/029290

Enrollment

Registered

2020-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: C140- Malignant neoplasm of pharynx, unspecified

Interventions

Intervention1: Concurrent chemoradiotherapy using combined Carboplatin (AUC 1.5) and Capecitabine(low dose) during the radiation period: 1. Inj. Carboplatin (AUC 1.5) every weekly 2. Tab. Capecitabin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed cases of head and neck squamous cell cancer 2. Performance status: ECOG scale 0 to 2. 3. Normal hemogram: i.e Hb.10%, TLC >4000/cumm, platelet count >100,000/cu mm. 4. Creatinine clearance >50ml/min

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in the study 2. Non squamous head and neck cancer 3. Uncontrolled diabetes, hypertension, acute or chronic kidney disease, congestive cardiac failure 4. HIV, HBV, HCV reactive disease 5. Concomitant administration of other experimental drugs 6. Previous radiotherapy to head and neck region

Design outcomes

Primary

Measure	Time frame
1. Objective early treatment response (using RECIST v.1.1) 2. Progression free survivalTimepoint: 1. Objective early treatment response will be evaluated at 6 months after treatment completion 2. Progression free survival will be assessed keeping patients on two monthly followup	—

Secondary

Measure	Time frame
1. Grade 3 or higher treatment toxicities 2. Duration of treatment interruption due to treatment related toxicitiesTimepoint: Both of the above parameters will be recorded during the treatment period	—

Countries

India

Contacts

Public ContactSrigopal Mohanty

Govt. Royapettah Hospital, attached to Govt. Kilpauk Medical College

sgd8gangadaran@gmail.com9841096885

Outcome results

None listed

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