Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT00652613 | Unknown Phase 2 DMC

• 1 other identifier: H&N_3DCRT_IMRT07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Head \& Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

3DCRT; IMRT; HNSCC; Quality of life; Major salivary gland sparing; Pattern of local and loco-regional recurrence; Disease Free Survival (DFS) & Overall Survival (OAS); Dose reduction to normal structures with IMRT

Outcome Measures

Primary Outcomes (2)

• Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage

  4 yrs

• Determine the pattern of local and loco-regional recurrence

  4 yrs

Secondary Outcomes (3)

• Disease Free Survival (DFS) and Overall Survival (OAS)

  4 yrs

• Quality of life 3. Dose to OAR

  4 yrs

• Assess the reduction in dose with IMRT to the normal larynx and normal pharyngeal constrictors in oropharyngeal cancers, uninvolved oral mucosa and auditory apparatus

  4 yrs

Study Arms (2)

1

ACTIVE COMPARATOR

3 dimensional conformal radiotherapy

Radiation: 3 Dimensional Radiation Therapy

2

EXPERIMENTAL

Intensity Modulated Radiation Therapy (IMRT)

Radiation: Intensity Modulated Radiation Therapy

Interventions

3 Dimensional Radiation Therapy RADIATION

Radiation with 6 MV photons to dose of 70Gy/ 35#/ 7 weeks

1

Intensity Modulated Radiation Therapy RADIATION

IMRT with 6 MV photons to a dose of 66Gy/30#/ 6 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
• AJCC stage T1-3, NO-2b, MO patients with pre-treatment tumor measurements clinically as well as on CT/MRI scans.
• Surgery of the primary tumor limited to excisional or incisional biopsy.
• No form of neck dissection for nodal metastases.
• KPS \> 60 (see appendix I).
• Age \> 18 and \< 65 years.
• No prior history of therapeutic irradiation.
• Patient willing and reliable for follow-up.
• Patient's nutritional \& physical condition compatible with planned therapy.

You may not qualify if:

• Evidence of distant metastases.
• Previous therapeutic irradiation for head \& neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin.
• History of prior malignancy.
• Prophylactic use of amifostine or pilocarpine.
• Active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
• Any histopathology other than Squamous Carcinoma.
• Primary nasopharyngeal carcinoma.
• Age \< 18 or \> 65 years.
• Pregnancy or lactating women.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (1)

• Ghosh-Laskar S, Yathiraj PH, Dutta D, Rangarajan V, Purandare N, Gupta T, Budrukkar A, Murthy V, Kannan S, Agarwal JP. Prospective randomized controlled trial to compare 3-dimensional conformal radiotherapy to intensity-modulated radiotherapy in head and neck squamous cell carcinoma: Long-term results. Head Neck. 2016 Apr;38 Suppl 1:E1481-7. doi: 10.1002/hed.24263. Epub 2015 Nov 11.

  PMID: 26561342 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Sarbani Ghosh-Laskar, MD

  Department of Radiation Oncology, Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

• Ketayun Dinshaw, FRCR

  Director, Tata Memorial Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 4, 2008
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: August 1, 2009
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

IN (1)