Clinical trial · Interventional
Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase II Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) vs Intensity Modulated Radiotherapy (IMRT) for Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Dimensional Radiation Therapy | Radiation | — | UNRESOLVED |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- 3 dimensional conformal radiotherapy
- interventionNames
- Radiation: 3 Dimensional Radiation Therapy
- type
- EXPERIMENTAL
- label
- 2
- description
- Intensity Modulated Radiation Therapy (IMRT)
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
Primary outcomes (2)
- measure
- Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage
- timeFrame
- 4 yrs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDGhosh-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