A Randomized Trial comparing 6 ½ weeks radiotherapy treatment (66 Grey total radiation dose) combined with chemotherapy versus 5 weeks accelerated radiotherapy alone (67.5 Grey) in Stage III/IV (locally advanced ) Oropharyngeal cancers.
- Conditions
- CANCER
- Registration Number
- CTRI/2012/01/002369
- Lead Sponsor
- PGIMER
- Brief Summary
Most of the indian patients are nutritionally compromised and are not able to tolerate the concurrent chemoradiation (current standard of care) along with radiation and experience severe toxicity leading to incomplete termination of the treatment (incomplete treatment) which results in poor disease control and recurrence. Concomitant boost radiotherapy is a novel form of altered fractionation scheme which has been well tested in RCTs giving superior results over conventional fractionation and a lesser toxicity than concurrent chemoradiation with better patient tolerance and compliance. There is a lack of RCT between these two treatment modalities in literature. Considering our indian patients, the result of this trial may guide the clinicians of this institute and elsewhere to choose between these two modality with greater confidence and an option of concomitant boost radiotherapy can always be offered to suitable patients omitting the added toxicity (acute and late) of the concurrent chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- 1.Biopsy proven cases of squamous cell carcinoma of oropharynx with no prior cancer directed treatment.
- 2.Tumor staged as III/IV as per the AJCC staging system.
- 3.Patient with a Karnofsky performance score (10) of 70 and above.
- 4.Patient who sign the informed consent and are ready to be on follow up as required.
- 1.Age < 18 years or >70 years 2.Pregnant women 3.Prior invasive malignancy.
- 4.Patients with simultaneous primaries or bilateral tumors are excluded 5.N3 nodal status.
- 6.Uncontrolled co morbid conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method locoregional control, 6 MONTHS disease free survival, 6 MONTHS
- Secondary Outcome Measures
Name Time Method acute and late toxicity, Quality of life
Trial Locations
- Locations (1)
Room No 6 (Head & Neck Cancers), department of radiotherapy, PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Room No 6 (Head & Neck Cancers), department of radiotherapy, PGIMER🇮🇳Chandigarh, CHANDIGARH, IndiaProf Sushmita GhoshalPrincipal investigator9914209394rtsushmita@gmail.com