Study of quality of life after completion of Re-Radiation treatment in Head and Neck Cancer patients

Recruiting

Conditions: patients receiving re-Irradiation (reRT).

Registration Number: CTRI/2018/03/012370

Brief Summary: Head and neck cancers form amajority of the cancers of developing world accounting for 23% of all cancer inmales and 6% in females in India.1 Aggressive locoregional treatmentis offered for these patients. Despite this the survivors remain at risk ofdeveloping recurrences which are common within first 2 years and the cumulativeestimated five year incidence of loco regional relapse is 29-31% in high riskpatients.2-4 Main site of failure of Head neck cancers islocoregional.5 Also the risk of second cancers which is about 5% peryear, the incidence being between 16-30%.6-8 Various factors affectthe risk of recurrence and second cancers.

The toxicity and quality oflife factors due to initial treatment may limit the ability to offer furtherradical treatment without increasing morbidity or affecting further the qualityof life of these patients. These factors have to be considered whileconsidering treatment decisions for treatment of these patients with a resultthat one or more modality may not be offered which otherwise would have beenoffered for patients with similar stage primary tumors.

The treatment of choice in acase of a recurrence or second neoplasm is salvage surgery. In case ofinoperable and/or unresectable cases, other modalities could be consideredincluding chemotherapy and radiation. Chemotherapy alone is essentiallypalliative and the results are quite dismal9 with response ratesbetween 10% and 40% and median survivals of six to eight months and no longterm survivors even with the best multidrug regimens10-13.

Radiotherapy is an importantmodality for primary treatment of head neck cancers and has been successfullyused at various subsites with success comparable to the surgery and with anadded advantage of organ preservation. Head and neck radiotherapy even for theprimary tumor is challenging because of the anatomy and the number of criticalorgans that are present very close to the target area. Another factor is thelate tissue toxicity. All these reduce the therapeutic ratio.

Concept of reirradiationwith curative intent has been used with judicious case selection of recurrence/ second primary by several institutions with varied success.14-21Complication rates after reirradiation vary from 7%to 50% but are higher forreirradiation of sites like the nasopharynxor PNS due to their proximity tocritical structures like brain, cranial nerves, and the orbits.15,22The aspects that are evaluated prior to reirradiation and determining the doseconstraints must be standardized. Due to the ability and availability todeliver precise and accurate radiotherapy using advanced delivery techniqueslike IMRT & IGRT, relatively better normal tissue sparing can be achieved.The study of these conformal techniques has been evaluated and found to givecomparable outcomes although the acute toxicity was high.23

Various factors affect thedecision for treatment. Factors related to the prior treatment as to the dose,fractionation, late effects and time interval since prior radiation, factorsrelated to the patient like performance status, age, comorbidities and factorsof the present tumor site, volume in previously irradiated region, ability tooffer surgery and / or radiotherapy need to be assessed and correlated with theoutcomes. Besides documentation of those who take treatment, their follow up toget an outcome would be reasonable. Besides documentation and reporting of theQuality of life is needed to assess the impact of benefit with reirradiation.

Swallowingdysfunction has been reported in 30-50% of patients of head and neck cancerstreated with intensive nonsurgical therapies.22-24 About one thirdof dysphagic patients develop aspiration pneumonia requiring treatment, withmortality rates ranging between 20% and 65%.25 Although dysphagiaimproves over time in 32% of HNCPs, 48% of patients fail to report improvementin dysphagia -associated symptoms and in 20% of patients symptoms worsenovertime.26 Dysphagia may pre-exist therapy (14% [27] to18% [28] of HNCPs) due to the obstruction by the tumour volume orinfiltration of structures involved with swallowing. In the operativepopulation, surgical extirpation of structures necessary for normal deglutitionresults in swallowing abnormalities. In the patients treated with radiotherapy(RT), dysphagia is secondary to damage of neural and soft tissues [29].

RT-induced swallowingdysfunction may occur both acutely during treatment and as a late effect of therapy.Radiation dose delivery to dysphagiaâ€“aspiration-related structures (DARSs),those anatomical structures that are critical to the swallowing function [30]has been shown to predict swallow outcome in a number of studies. DARScomprise of the superior, middle and inferior pharyngeal constrictor muscles,cricopharyngeus muscle, esophagus inlet muscles, cervical esophagus, base oftongue, supraglottic larynx and glottic larynx . Severity of dysphagia increasewith the dose received by the pharyngeal constrictors (31) but italso increases with the volume of the pharyngeal constrictors irradiated (31,32,33).The volume of the middle pharyngeal constrictor muscle receiving 50 Gy (p =0.04), the mean dose to this structure (p = 0.02) and to the supraglottic larynx(p = 0.04) were significantly associated with late swallowing problems. It hasbeen seen that while treating orophryngeal cancer with IMRT technique, dose tosuperior pharyngeal constrictors and myo/geniohyoid complex should be monitoredand constrained whenever possible .34 The volume of the larynx receiving >or=50Gy (p = 0.04 andp = 0.03, respectively) and volume of the inferior constrictor receiving>or=50Gy (p = 0.05 and p = 0.02, respectively) were significantly associatedwith both aspiration and stricture.33

All these data are from reports on patientsreceiving primary therapy. In patients receiving re RT, Quality of life relatedto swallowing is already impaired due to prior

therapies and there is paucity of data regarding swallowingoutcomes, doses that can be delivered without worsening swallowing outcomes andfactors that predict

worse swallowing outcomes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 200

Inclusion Criteria

Patients must have recurrence/ second primary (SPN) at least 6 months after prior radiotherapy.
Patients should have histopathological proof for both the primary tumor and at recurrence / second cancer in the head and neck region.
Patients should have been treated with radical intent for primary tumor with appropriate radical doses of radiation.
Patients who are diagnosed with recurrent or second cancer for which the radiation portals will overlap the fields of previously irradiated region.
In the recurrent setting the intention of treatment is radical.

Exclusion Criteria

1.Patients having recurrence/ second primary (SPN) before completion of 6 months of prior radiotherapy.
2.Patients being treated with palliative intent in recurrent setting.
3.Radiation portals not overlapping the fields of previously irradiated region.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To document and evaluate change in quality of Life in patients receiving reRT for recurrence or second primary.	After Completion of Radiation therapy

Secondary Outcome Measures

Name	Time	Method
1.To evaluate changes in swallowing function, in patients receiving reRT.	2.To establish dosimetric relationship between Dysphagia Aspiration Related Structures and severity of swallowing dysfunction in patients receiving Re-RT.

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Sarbani Ghosh Laskar
Principal investigator
9820834386
sarbanilaskar@gmail.com