A randomised phase III clinical trial to evaluated effect of induction chemotherapy and dysphagia optimized intensity modulated radiotherapy for management of pharyngeal tumors

Phase 3

• Conditions: Health Condition 1: C01- Malignant neoplasm of base of tongueHealth Condition 2: C13- Malignant neoplasm of hypopharynxHealth Condition 3: C10- Malignant neoplasm of oropharynxHealth Condition 4: C12- Malignant neoplasm of pyriform sinusHealth Condition 5: C09- Malignant neoplasm of tonsil

• Registration Number: CTRI/2024/05/068091
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Aged 18 years or above

2. Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx.

3.Patients with tumor at other sites where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible

4.Stage T1-4,N03,M0 disease;

5. this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types may be eligible.

6. Radiotherapy with concomitant chemotherapy (unless contra-indicated) is the planned treatment

7.WHO performance status 0 or 1

8. Must be available to attend long term follow up

9.Adequate cognitive ability to complete the questionnaires

10. Written informed consent.

Exclusion Criteria

1.Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer).

2.Previous radiotherapy to the head and neck region.

3.Any contra-indication to Chemotherapy/Radiotherapy

4.Posterior pharyngeal wall, post cricoid or retropharyngeal lymph node involvement.

5.Lateralized tumors, requiring unilateral neck irradiation.

6.Major head and neck surgery (excluding biopsies/tonsillectomy).

7.Current/previous tracheostomy placement.

8.Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up.

9.Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ)

Study & Design

• Study Type: Interventional
• Study Design: Not specified