Trial comparing the effectiveness of daily radiation therapy plus a second daily radiation boost dose with daily radiation therapy plus three-weekly chemotherapy in advanced cancers of the head and neck.

A prospective comparative study between concurrent chemoradiation versus conventional radiation with daily concomitant boost to the gross disease in locally advanced squamous cell cancers of the head and neck.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012579

Enrollment

Registered

2018-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Locoregionally advanced squamous cell carcinoma of the head and neck

Interventions

Intervention1: Acceleraed Fractionated Radiotherapy with Concomitant Boost: 66 to 70 Gy in 33 to 35 fractions, 1.8 to 2 Gy per fraction, 1 fraction per day from monday to friday, 5 fractions per week,

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven squamous cell cancers of oropharynx, hypopharynx, or larynx. AJCC stage T2N1-3M0 or T3-4N0-3M0. ECOG PS 0-2. No prior surgery except biopsy. No prior chemotherapy and/or radiotherapy. No evidence of uncontrolled cardiorespiratory, hepatic, renal, or hematological comorbidities.

Exclusion criteria

Exclusion criteria: Lack of histopathological proof. Nonsquamous histology. Sites like oral cavity, nasopharynx, nasal cavity, paranasal sinuses, salivary glands, orbit, brain, skin. Prior surgery except biopsy. Prior radiotherapy and/or chemotherapy. Pregnancy or lactation. Evidence of systemic metastases.

Design outcomes

Primary

Measure	Time frame
Locoregional ResponseTimepoint: 6 weeks from treatment completion.	—

Secondary

Measure	Time frame
Acute ToxicitiesTimepoint: Weekly examination during treatment, 2 weeks after treatment completion, 6 weeks after treatment completion.;Death due to any causeTimepoint: Date of death, as communicated to the principal investigator.;Late ToxicitiesTimepoint: Regular follow up at 1-3 month intervals;Locoregional or Distant FailureTimepoint: 6 weeks from treatment completion, then regular follow ups at 1-3 months interval.	—

Measure

Time frame

Acute ToxicitiesTimepoint: Weekly examination during treatment, 2 weeks after treatment completion, 6 weeks after treatment completion.;Death due to any causeTimepoint: Date of death, as communicated to the principal investigator.;Late ToxicitiesTimepoint: Regular follow up at 1-3 month intervals;Locoregional or Distant FailureTimepoint: 6 weeks from treatment completion, then regular follow ups at 1-3 months interval.

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Countries

India

Contacts

Public ContactBodhisattwa Dutta

Medical College And Hospital, Kolkata

asitrdeb@rediffmail.com

Outcome results

None listed

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